Country	Organization	Document	Status	Category
International	WHO	Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products (QAS/24.956)	Draft	Application Process, Procedural
International	WHO	Guidance for the graphic representation of pharmaceutical substances in the publications of International Nonproprietary Names and The International Pharmacopoeia (QAS/17.726)	Draft	Procedural, Quality, Manufacturing, GMP
International	WHO	Notes on the Design of Bioequivalence Study: Lamivudine/Tenofovir Disoproxil Fumarate/Dolutegravir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Medroxyprogesterone Acetate/Estradiol Cypionate	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the design of bioequivalence study: Nirmatrelvir + Ritonavir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Rifampicin/Clarithromycin	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Sofosbuvir/Daclatasvir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Sofosbuvir/Ledipasvir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Atazanavir/Ritonavir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Ethinylestradiol/Desogestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Ethinylestradiol/Levonorgestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Glecaprevir/Pibrentasvir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Isoniazid/Pyrazinamide/Rifampicin	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the design of Bioequivalence study: Isoniazid/Rifampicin	Final	Generics, Product Development, Bioequivalence
International	ICH	M13A Bioequivalence For Immediate-Release Solid Oral Dosage Forms	Final	Bioequivalence
International	ICH	M13A Q&As Bioequivalence For Immediate-Release Solid Oral Dosage Forms	Final	Bioequivalence
International	ACCESS Consortium	Operational Procedures - Generic Medicines Work-Sharing Initiative (GMWSI)	Final	Application Process, Generics
Australia	TGA	Therapeutic Goods Order No. 70C (TGO70C) – Standards for Export Only Medicine	Draft	Trade, Quality
Australia	TGA	Established acceptable intake for nitrosamines in medicines	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
Australia	TGA	GMP surveillance inspections and extended validity of TGA GMP certificates	Final	Manufacturing, GMP, Inspections, Compliance
Australia	TGA	Adoption of EMA’s version of ICH M9 guideline on biopharmaceutics classification system-based biowaivers (ICH M9; EMA/CHMP/ICH/493213/2018)	Final	Quality, Safety, Efficacy, Generics, Clinical Trials
Australia	TGA	Adoption of ICH harmonised guideline – S11 Nonclinical safety testing in support of development of paediatric pharmaceuticals	Final	Safety, Pediatrics, Toxicology
Australia	TGA	Adoption of ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population	Final	Efficacy, Pediatrics, Clinical Trials
Australia	TGA	Adoption of EMA’s version of ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals (ICH S1B(R1); EMA/774371/2022)	Final	Safety
Australia	TGA	Adoption of US FDA guideline on Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies	Final	Clinical Trials, Oncology, Clinical, Medical
Australia	TGA	Adoption of ICH M8 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.5	Final	Application Process, Electronic Submission
Australia	TGA	TGA Implementation of ICH eCTD v4.0 Specification	Final	Application Process, Electronic Submission
Australia	TGA	Adoption of EMA Guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/205/95 Rev. 5)	Final	Clinical Trials, Oncology, Clinical, Medical
Australia	TGA	Adoption of EMA’s version of ICH guideline E8 (R1) on general considerations for clinical studies – Step 5 (ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr)	Final	Clinical Trials, Efficacy
Australia	TGA	Adoption of EMA’s version of ICH guideline Q3C (R8) on impurities: guideline for residual solvents – Step 5 (ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr)	Final	Quality, Safety, Manufacturing, GMP
Australia	TGA	Adoption of EMA’s version of ICH guideline M7(R2) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5 (ICH M7 (R2); EMA/CHMP/ICH/83812/2013)	Final	Safety, Toxicology
Australia	TGA	Adoption of EMA’s version of ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 5 (ICH M7 (R2); EMA/CHMP/ICH/5072766/2021)	Final	Safety, Toxicology
Australia	TGA	Adoption of EMA’s version of ICH guideline M10 on bioanalytical method validation and study sample analysis – Step 5 (ICH M10; EMA/CHMP/ICH/172948/2019)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA’s version of ICH guideline Q3D (R2) on elemental impurities - Step 5 (ICH Q3D (R2); EMA/CHMP/ICH/353369/2013)	Final	Quality, Safety
Australia	TGA	Adoption of EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) (EMA/CHMP/BWP/247713/2012)	Final	Biosimilars, Quality
Australia	TGA	Adoption of EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005 Rev1)	Final	Biosimilars, Clinical
Australia	TGA	Adoption of EMA Guideline on similar biological medicinal products containing interferon beta (EMA/CHMP/BMWP/652000/2010)	Final	Biosimilars
Australia	TGA	Adoption of EMA Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues (EMA/CHMP/BMWP/403543/2010)	Final	Biosimilars
Australia	TGA	Adoption of EMA Guideline on Quality of biological active substances produced by transgene expression in animals (EMA/CHMP/BWP/151897/2013)	Final	Biologicals, Manufacturing
Australia	TGA	Adoption of EMA Guideline on the clinical development of medicinal products intended for the treatment of pain (EMA/CHMP/970057/2011)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD) (EMEA/CHMP/EWP/431734/2008)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on pharmaceutical development of medicines for paediatric use (EMA/CHMP/QWP/805880/2012 Rev. 2)	Final	Pediatrics, Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use (CPMP/BPWG/575/99 Rev. 1)	Final	Blood products, Efficacy
Australia	TGA	Adoption of EMA Guideline on plastic immediate packaging materials (CPMP/QWP/4359/03, EMEA/CVMP/205/04)	Final	Packaging
Australia	TGA	Adoption of EMA Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer (EMA/CHMP/BWP/271475/2006 rev.1)	Final	Oncology, Biologicals
Australia	TGA	Adoption of EMA Guideline on process validation for finished products - information and data to be provided in regulatory submissions (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1)	Final	Quality, Manufacturing
Australia	TGA	Adoption of EMA Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (EMA/CHMP/BWP/187338/2014)	Final	Biologicals, Manufacturing, CMC, Chemistry, Manufacturing and Controls
Australia	TGA	Adoption of EMA Guideline on registry-based studies (EMA/426390/2021)	Final	Clinical Trials, Real World Data
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) (CHMP/BPWP/410415/2011 Rev 1)	Final	Efficacy, Safety, Blood Products
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of human plasma derived von Willebrand factor products (CPMP/BPWG/220/02)	Final	Efficacy, Safety, Blood Products
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Axial Spondyloarthritis (CPMP/EWP/4891/03 Rev 1, Corr 1)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of medicinal products indicated for the treatment of panic disorder (CHMP/EWP/4280/02)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency (EMA/CHMP/500825/2016)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease (CPMP/EWP/553/95 Rev. 2)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products (CPMP/BPWG/1089/00)	Final	Clinical, Medical, Efficacy, Blood Products
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144533/2009 rev. 1)	Final	Clinical, Medical, Efficacy, Blood Products
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (CHMP/EWP/89249/2004)	Final	Clinical, Medical, Efficacy, Pharmacology
Australia	TGA	Adoption of EMA Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (EMEA/CHMP/EWP/356954/2008)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the development of medicinal products for the treatment of alcohol dependence (EMA/CHMP/EWP/20097/2008)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia (EMA/CHMP/153191/2013)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases (CHMP/EWP/18504/2006)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease (CHMP/EWP/1343/01 Rev. 1)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C (EMEA/CHMP/EWP/30039/2008)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical evaluation of medicinal products intended for treatment of hepatitis B (CHMP/EWP/6172/03)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of anti-anginal medicinal products in stable angina pectoris (CPMP/EWP/234/95/rev. 1)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the clinical investigation of hepatitis B immunoglobulins (CHMP/BPWP/585257/2009)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA Guideline on the choice of the non-inferiority margin (EMEA/CPMP/EWP/2158/99)	Final	Clinical Trials, Biostatistics
Australia	TGA	Adoption of EMA Guideline on stability testing for applications for variations to a marketing authorisation (EMA/CHMP/CVMP/QWP/441071/2011 Rev. 2)	Final	Quality, Variations
Australia	TGA	Adoption of EMA Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products (CPMP/QWP/122/02, rev 1 corr)	Final	Quality, Manufacturing, GMP
Australia	TGA	Adoption of EMA Guideline on summary of requirements for active substances in the quality part of the dossier (CHMP/QWP/297/97 Rev 1 corr, EMEA/CVMP/1069/02)	Final	Quality, Manufacturing, GMP
Australia	TGA	Adoption of EMA Guideline on the chemistry of new active substances (CPMP/QWP/130/96 Rev 1)	Final	Quality
Australia	TGA	Adoption of EMA Guideline on the clinical development of medicinal products for the treatment of allergic rhino-conjunctivitis (CHMP/EWP/2455/02)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the clinical development of medicinal products for the treatment of HIV infection (EMEA/CPMP/EWP/633/02 Rev. 3)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on quality of oral modified release products (EMA/CHMP/QWP/428693/201)	Final	Quality
Australia	TGA	Adoption of EMA Guideline on reporting the results of population pharmacokinetic analyses (CHMP/EWP/185990/06)	Final	Pharmacology, Bioequivalence
Australia	TGA	Adoption of EMA Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling (EMEA/CHMP/203927/2005)	Final	Safety, Pharmacovigilance, Labeling
Australia	TGA	Adoption of EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012)	Final	Quality, Safety, Manufacturing, GMP, Inspections, Compliance
Australia	TGA	Adoption of EMA Guideline on radiopharmaceuticals (EMEA/CHMP/QWP/306970/2007)	Final	Clinical, Medical, Radiopharmaceuticals
Australia	TGA	Adoption of EMA Guideline on production and quality control of animal immunoglobulins and immunosera for human use (EMA/CHMP/BWP/3354/1999 rev.1)	Final	Biologicals, Manufacturing
Australia	TGA	Changes to the Permissible Ingredients Determination	Final	Safety, Compliance
Australia	TGA	Submitting a Drug Master File (DMF)	Final	Application Process, Procedural, Quality, CMC, Chemistry, Manufacturing and Controls
Australia	TGA	Form - Report a perceived breach or questionable practices	Final	Compliance, Administrative
Australia	TGA	Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure	Final	Safety
Belgium	CT-College	Recommendation of the College Board regarding the use of force majeure (Version 1.0)	Final	Clinical Trials
Belgium	CT-College	Recommendations of the College Board to reduce the number of RFIs raised during the assessment of a clinical study (Version 1.0)	Final	Clinical Trials
Belgium	CT-College	Advice by the Belgian Association of Research Ethics Committees (BAREC) for patient facing documents endorsed by the College Board	Final	Clinical Trials
Bulgaria	BDA	Notice to sponsors of clinical trials	Final	Clinical Trials
Canada	HC	Draft guidance on expanded access clinical trials	Draft	Compassionate Use
Canada	HC	Release of draft (Step 2) ICH Guideline M14: General principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines	Draft	Real World Data, Real World Evidence
Canada	HC	Regulatory Requirements for Drug Identification Numbers (DINs)	Final	Safety, Pharmacovigilance, Procedural
Canada	HC	Established acceptable intake (AI) limits for N-nitrosamine impurities - Appendix 1 to Health Canada's Guidance on nitrosamine impurities in medications	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
Denmark	DMA	Guideline for applications for authorisation of clinical trials of medicinal products in humans	Final	Clinical Trials
Denmark	DMA	Clinical trials - questions and answers	Final	Clinical trials
Denmark	DMA	Deregistration of medicinal products	Final	Procedural, Administrative
Egypt	EDA	Guideline for Post Market Quality Monitoring of Biological Products in Egypt (Version 1)	Final	Safety, Pharmacovigilance, Biologicals
Egypt	EDA	Procedures of scientific advice for biological products (Version 1)	Final	Application Process, Procedural
Ethiopia	EFDA	Guideline on Reliance for cGMP inspection (Version 1)	Final	Manufacturing, GMP, Inspections, Compliance
EU	EC	Clinical Trials Regulation (EU) No 536/2014 - Questions & Answers (Version 6.9)	Final	Clinical Trials
EU	EC	EU Module 1 eCTD Specification (Version 3.1)	Final	Application Process, Electronic Submission
EU	HMA	CTCG Template: Initial application cover letter (To be used for the initial application (or resubmission) of new clinical trials), Version 1	Final	Clinical Trials
EU	HMA	CTCG Template: Substantial Modification Cover Letter (Version 2.0)	Final	Clinical Trials
EU	HMA	CTCG Template: Substantial Modification description (Version 2.0)	Final	Clinical Trials
EU	HMA	CTCG Template: RFI Response List of Changes to the Application (Version 1)	Final	Clinical Trials
EU	HMA	Cover Letter Template for first SM after transition – Annex I to CTCG Best Practice Guide to sponsors – first substantial modification application Part I and/or Part II after CTR transition (Version 2)	Final	Clinical Trials
EU	HMA	Substantial Modification Description Template - first SM after transition – Annex II to CTCG Best Practice Guide to sponsors – first substantial modification application Part I and/or Part II after CTR transition (Version 2)	Final	Clinical Trials
EU	HMA	First SM Part II after transition – Annex III to CTCG Best Practice Guide to sponsors – first substantial modification application Part I and/or Part II after CTR transition (Version 1)	Final	Clinical Trials
EU	HMA	CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials	Final	Clinical Trials
EU	CMDh	Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers (CMDh/043/2007, Rev.20) [Track version]	Final	Application Process, Procedural
EU	CMDh	Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures (CMDh/085/2008, Rev.27) [Track version]	Final	Application Process, Procedural
EU	CMDh	Template: Cover letter for new applications submitted through MRP/DCP (CMDh/226/2007 Rev.10) [Track version]	Final	Application Process, Procedural
EU	CMDh	Form - EU Active Substance Master File (ASMF) number request form (CMDh/307/2013, Rev.4) [Track version]	Final	Quality, GMP, Manufacturing, Variation
EU	CMDh	CMDh Best Practice Guide on Multilingual Packaging (CMDh/413/2019/Rev. 5) [Track version]	Final	Labeling, Packaging, Distribution
EU	CMDh	Template: Notification for Product Information amendment under Article 61(3) (Not accompanying a variation change)	Final	Product Information, Labeling
EU	CMDh	“Blue – Box” requirements (CMDh/258/2012, Rev.26) [Track version]	Final	Labeling, Packaging, Distribution
EU	CMDh	Template: Request for MRP/RUP/Update assessment report (CMDh/442/2022, Rev 4) [Track version]	Final	Application Process, Procedural
EU	EMA	Concept paper on the need for a reflection paper on assessment of cardiovascular safety of oncology medicinal products (EMA/CHMP/322756/2024)	Draft	Oncology, Toxicology
EU	EMA	Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products (EMA/CHMP/315603/2024)	Draft	Product Development, Bioequivalence
EU	EMA	Guideline on the chemistry of active substances (EMA/321776/2024)	Draft	Quality
EU	EMA	Draft guideline on the development and manufacture of oligonucleotides (EMA/CHMP/CVMP/QWP/262313/202424)	Draft	Quality, Clinical, Medical
EU	EMA	Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals (EMA/336761/2024)	Draft	Vaccines, Clinical, Medical
EU	EMA	Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance (EMA/CHMP/254395/2024)	Draft	Generics, Product Development, Bioequivalence
EU	EMA	Product Lifecycle Management Portal – Human Variations eAF: Guide to navigation (Version 1.4)	Draft	Variations, Electronic Submissions
EU	EMA	Revised CTIS transparency rules and historical trials: quick guide for users (Version 1.7)	Final	Clinical Trials, Compliance
EU	EMA	Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions (EMA/340669/2024)	Final	Safety, Pharmacovigilance
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Annex I – Definitions (EMA/876333/2011 Rev 5)	Final	Safety, Pharmacovigilance
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures (EMA/204715/2012 Rev 3)	Final	Safety, Pharmacovigilance
EU	EMA	Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures (EMA/419982/2019)	Final	Safety, Pharmacovigilance
EU	EMA	Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)/Product Management System (PMS) entries (EMA/348294/2024)	Final	Product Information, Compliance, Supply, Distribution
EU	EMA	Form - Proposed invented name(s) request form for human medicinal products	Final	Application Process, Procedural
EU	EMA	ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines (EMA/CHMP/ICH/295401/2023)	Final	Real World Data, Real World Evidence
EU	EMA	ICH M13A Guideline on bioequivalence for immediate release solid oral dosage forms - Step 5 (EMA/CHMP/ICH/953493/2022)	Final	Bioequivalence
EU	EMA	ICH M13A Guideline on bioequivalence for immediate-release solid oral dosage forms - Questions and answers (EMA/CHMP/ICH/325575/2024)	Final	Bioequivalence
EU	EMA	Quality systems framework for GMP inspectorates	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Management of rapid alerts arising from quality defects risk assessment	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Conduct of inspections of pharmaceutical manufacturers or importers	Final	Manufacturing, GMP, Inspections, Compliance, Trade
EU	EMA	Outline of a procedure for co-ordinating the verification of the GMP status of manufacturers in third countries	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Guideline on training and qualifications of GMP inspectors	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	The issue and update of GMP certificates	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	A model for risk based planning for inspections of pharmaceutical manufacturers	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Procedure for dealing with serious GMP non-compliance information originating from third country authorities or international organisations	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Guideline on training and qualification of inspectors performing inspections of wholesale distributors	Final	Distribution, Inspections, Compliance
EU	EMA	Good distribution practice (GDP) inspection procedure	Final	Distribution, Inspections, Compliance
EU	EMA	The issue and update of good distribution practice (GDP) certificates	Final	Distribution, Inspections, Compliance
EU	EMA	Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Procedure for compliance management	Final	Manufacturing, GMP, Distribution, Inspections, Compliance
EU	EMA	Interpretation of the Union format for manufacturer/importer authorisation	Final	Trade, Manufacturing, GMP, Procedural
EU	EMA	Interpretation of the Union format for good manufacturing practice (GMP) certificate	Final	Manufacturing, GMP, Procedural, Inspections, Compliance
EU	EMA	Interpretation of the Union format for a wholesale distribution authorisation	Final	Distribution, Procedural, Trade
EU	EMA	Good manufacturing practice (GMP) inspection report – Union format	Final	Manufacturing, GMP, Procedural, Inspections, Compliance
EU	EMA	Union format for manufacturer’s authorisation	Final	Manufacturing, GMP, Procedural, Trade
EU	EMA	Union format for a good manufacturing practice (GMP) certificate	Final	Manufacturing, GMP, Procedural, Inspections, Compliance
EU	EMA	Statement of non-compliance with good manufacturing practice (GMP)	Final	Manufacturing, GMP, Procedural, Inspections, Compliance
EU	EMA	Notification of serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations	Final	Manufacturing, GMP, Procedural, Inspections, Compliance
EU	EMA	Union format for a good distribution practice (GDP) certificate for active substances to be used as starting materials in medicinal products	Final	Distribution, Procedural, Inspections, Compliance
EU	EMA	Good distribution practice (GDP) inspection report – Union format	Final	Distribution, Procedural, Inspections, Compliance
EU	EMA	Union format for a wholesale distribution authorisation	Final	Distribution, Procedural, Trade
EU	EMA	Statement of non-compliance with good distribution practice	Final	Distribution, Procedural, Inspections, Compliance
EU	EMA	Statement of non-compliance with good distribution practice of a distributor of active substances for use as starting materials in medicinal products	Final	Distribution, Procedural, Inspections, Compliance
EU	EMA	Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA	Final	Manufacturing, Procedural
EU	EMA	Union format for registration of manufacturer, importer or distributor of active substance	Final	Manufacturing, GMP, Distribution, Procedural, Trade
EU	EMA	Frequently Asked Questions (FAQs) on the European Shortages Monitoring Platform (ESMP)	Final	Supply, Distribution, Compliance
EU	EMA	European Shortages Monitoring Platform (ESMP) Implementation Guide for Marketing Authorisation Holders (Version 1.0)	Final	Supply, Distribution, Compliance
EU	EMA	European Shortages Monitoring Platform (ESMP): Marketing authorisation holder reporting templates	Final	Supply, Distribution, Compliance
EU	EMA	European Shortages Monitoring Platform (ESMP) Implementation Guide for National Competent Authorities (Version 1.0)	Final	Supply, Distribution, Compliance
EU	EMA	European Shortages Monitoring Platform (ESMP): National competent authority reporting templates	Final	Supply, Distribution, Compliance
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev. 140)	Final	Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 124)	Final	Safety, Pharmacovigilance
EU	EMA	Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance	Final	Safety, Pharmacovigilance
EU	EMA	Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 1 - Registration requirements (EMA/676105/2019), Version 4	Final	Application Process, Procedural, Product Information, Pharmacovigilance, Safety
EU	EMA	Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004 - Chapter 3.II: XEVPRM User Guidance (EMA/135580/2012), Version 3.17	Final	Electronic Submission, Procedural, Compliance, Administrative, Safety, Pharmacovigilance
EU	EMA	EMA confirms its recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025 (EMA/338472/2024)	Final	Vaccines
EU	EMA	Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (EMA/409815/2020 Rev.21)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
EU	EMA	Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction – Chapter 5: Data access to medicinal products for human use - Annex A: Product data elements accessible by stakeholder group (EMA/8806/2024)	Final	Procedural, Administrative
EU	EMA	Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group (EMA/934543/2022 Rev. 4)	Final	Procedural, Product Information, Labeling
EU	EMA	Member states contact points for review of national versions of the content of mobile scanning and other technologies (EMA/358267/2015 Rev. 11)	Final	Procedural, Product Information
EU	EMA	Procedural advice on paediatric applications - Guidance for applicants (EMA/672643/2017 Rev. 10)	Final	Clinical Trials, Pediatrics
EU	EMA	eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual (Version 5.9)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Member states contact points for translations review (EMA/102302/2005 v. 6.6)	Final	Procedural
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.69)	Final	Procedural, Compliance, Administrative
EU	EMA	QRD Appendix V - Adverse-drug-reaction reporting details (EMA/67830/2013, Version 30)	Final	Procedural, Compliance, Administrative
Hong Kong	DoH	Revised Good Manufacturing Practice Guide (Effective from 1 July 2025)	Final	Manufacturing, GMP, Inspections, Compliance
Hong Kong	DoH	Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products	Final	Packaging Manufacturing, GMP, Inspections, Compliance
Hong Kong	DoH	Form - Application for Renewal of Registration as Authorized Person	Final	Manufacturing. GMP, Supply, Procedural
India	CDSCO	General Statutory Rule (GSR) 391(E) - Inclusion of details of excipient on every strip of medicines under Rule 96, in sub-rule (7) of Drugs Rules, 1945	Draft	Labeling
India	CDSCO	General Statutory Rule (GSR) 375(E) - Notification for No Advertisements of Drugs Specified in Schedule G under Drugs Rules, 1945	Draft	Advertising
India	CDSCO	Circular regarding Requirement of Toxicity Studies for New Drugs, Subsequent New Drugs (SNDs) and Fixed Dose Combinations (FDCs)	Final	Pharmacology, Toxicology, Safety
Italy	AIFA	Additional requirements for creating the eCTDs to be submitted on the CESP Portal	Final	Application Process
Japan	PMDA	Planning of the Pediatric Drug Development Program during Development of Drugs for Adults [Provisional Translation], Published June 2024	Final	Pediatrics, Clinical, Medical
Japan	PMDA	Partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults” [Provisional Translation], Published June 2024	Final	Pediatrics, Clinical, Medical
Japan	PMDA	Q&A for “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults” [Provisional Translation], Published June 2024	Final	Pediatrics, Clinical, Medical
Japan	PMDA	Questions and Answers (Q&A) for Extension of Re-Examination Period in Association with Development of Pediatric Dosage and Administration [Provisional Translation], Published June 2024	Final	Pediatrics, Procedural
Japan	PMDA	Partial Revision of “Designation of Orphan Drugs etc.” [Provisional Translation], Published June 2024	Final	Orphans, Rare Diseases
Japan	PMDA	Questions and Answers (Q&A) for “Designation of Orphan Drugs etc.” [Provisional Translation], Published June 2024	Final	Orphans, Rare Diseases
Japan	PMDA	Partial Revision of “Handling of Re-Examination Period” [Provisional Translation], Published June 2024	Final	Application Process, Procedural
Japan	PMDA	Handling of Designation of Drugs for Specific Use [Provisional Translation], Published June 2024	Final	Application Process, Procedural
Japan	PMDA	Re-Examination Period of Prescription Drugs [Provisional Translation], Published June 2024	Final	Application Process, Procedural
Latvia	SAMLV	Submission and approval of educational materials stipulated by the risk management plan at the State Agency of Medicines (Version 2)	Final	Safety, Pharmacovigilance
Latvia	SAMLV	Submission and agreement of Direct Healthcare Professional Communications with the State Agency of Medicines (Version 2)	Final	Safety, Pharmacovigilance
Malaysia	NPRA	Drug Registration Guidance Document (DRGD), Third Edition, Eighth Revision	Final	Application Process
Malta	MMA	Guidelines for the Advertising of Medicinal Products for Human Use	Final	Advertising, Promotion
Pakistan	DRAP	Bioequivalence and Bioavailability of Drug Products	Final	Bioequivalence, Generics
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore (TPB-GN-005-013)	Final	Application Process, Procedural
Singapore	HSA	FAQs - Guidance on the Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers	Final	Manufacturing, GMP, Quality, Application Process
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 1 Patent Declaration Forms (TPB-SUB-002-006), Version 7	Final	Application Process, IP, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 2A Application Checklist (ICH CTD – NDA and GDA) (TPB-SUB-003-009), Version 10	Final	Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 3A Application Checklist (ASEAN CTD – NDA and GDA) (TPB-SUB-005-009), Version 10	Final	Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 5 Target Processing Timelines (TPB-GN-007-003)	Final	Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 6 Guideline on Submission for Non-Prescription Therapeutic Products (TPB-GN-008-001)	Final	Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 7A Guidance on Electronic Labelling for Therapeutic Products (TPB-GN-021-001)	Final	Labeling
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 11 Guideline on Drug Master File (DMF), TPB-GN-013-006	Final	Application Process, Procedural, Quality, CMC, Chemistry, Manufacturing and Controls
Singapore	HSA	Minor variation (MIV) self-guided tool	Final	Variations, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 13 Guideline on Minor Variation Applications for Chemical Therapeutic Products (TPB-GN-014-005)	Final	Variations, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 13A - Part A: Checklist on Dossier Requirements for MIV-1 Variation (TPB-SUB-010-006)	Final	Variations, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 13B - Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation (TPB-SUB-011-005)	Final	Variations, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 13C - Part C: Checklist on Dossier Requirements for MIV-2 (do-and-tell) Variation (TPB-SUB-018-005)	Final	Variations, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 14 Guideline on Minor Variation Applications for Biological Therapeutic Products (TPB-GN-015-004)	Final	Variations, Biologics, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 14A - Part A: Checklist on Dossier Requirements for MIV-1 Variation (TPB-SUB-012-006)	Final	Variations, Biologics, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 14B - Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation (TPB-SUB-013-004)	Final	Variations, Biologics, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 14C - Part C: Checklist on Dossier Requirements for MIV-2 (do-and-tell) Variation (TPB-SUB-019-004)	Final	Variations, Biologics, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 17 Guideline on PRISM Submission (TPB-GN-018-005)	Final	Application Process, Variations, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 18 Confirmation of Quality Dossiers with Reference Agency’s Approval (TPB-GN-019-003)	Final	Quality, Manufacturing, GMP, Chemistry, Manufacturing and Controls, CMC, Application Process, Procedural
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore - Appendix 18A Dossier Clarification Supplement (TPB-SUB-017-003)	Final	Quality, Manufacturing, GMP, Chemistry, Manufacturing and Controls, CMC, Application Process, Procedural
South Africa	SAHPRA	Guideline on Co-Applicancy (Version 1)	Final	Application Process
South Africa	SAHPRA	Guideline for the API Master File (APIMF) Procedure (Version 4)	Final	Quality, Safety, Efficacy, Application Process, Procedural
South Africa	SAHPRA	Communication: Phenylephrine - Lack of effectiveness of oral preparations as nasal decongestant	Final	Safety, Compliance
South Africa	SAHPRA	Communication: Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers	Final	Safety, Compliance, Labeling, Product Information
South Africa	SAHPRA	Communication: Medicines Registration Renewals Implementation Framework (Version 7)	Final	Application Process, Procedural
South Africa	SAHPRA	Communication: Frequently asked questions (FAQs) on Active Pharmaceutical Ingredient	Final	Quality, Manufacturing, GMP
South Africa	SAHPRA	Communication: Frequently asked questions and common deficiencies for the submission of PEM Post-Registration variations	Final	Variations, Quality
South Africa	SAHPRA	Communication: Implementation of the Regulatory Information Management System (RIMS) Portal and Interim Digital Variations Portal (DVP) use (Version 5)	Final	Procedural, Administrative, Variations
South Africa	SAHPRA	Form - CTD Checklist (Revision 1)	Final	Variations, Application Process, Procedural
South Africa	SAHPRA	Form- Z-Code Request Form (Revision 1)	Final	Procedural, Administrative
Switzerland	Swissmedic	ICH M14 General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines	Draft	Real World Data, Real World Evidence
Switzerland	Swissmedic	Guidance document - Packaging for human medicinal products (Version 5.0)	Final	Packaging
Switzerland	Swissmedic	Form - Application form for Temporary Authorization	Final	Procedural, Application Process
Switzerland	Swissmedic	Information sheet - Guidance for Industry Electronic exchange of ICSRs through PV Gateway (Version 6.0)	Final	Safety, Pharmacovigilance
Switzerland	Swissmedic	Order form for a CPP (Certificate of a Pharmaceutical Product)	Final	Manufacturing, Trade
Switzerland	Swissmedic	Guidance document - Product information for human medicinal products (Version 5.0)	Final	Product Information
Uganda	NDA	Guidelines on Good Manufacturing Practice for Medicinal Products Part 1 – Basic Requirements for Medicinal Products (Revision 5)	Final	Manufacturing, GMP, Inspections, Compliance
Uganda	NDA	Guidelines on Good Manufacturing Practice for Medicinal Products Part II - Basic Requirements for Active Pharmaceutical Ingredients (Revision 2)	Final	Manufacturing, GMP, Inspections, Compliance
Uganda	NDA	Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision 4)	Final	Manufacturing, GMP, Inspections, Compliance
UK	HRA	Changes to progress and safety reports	Final	Clinical Trials
UK	MHRA	Access New Active Substance and Biosimilar Work Sharing Initiatives	Final	Procedural, Application Process
UK	MHRA	International Recognition Procedure (IRP) Lifecycle Validation Checklist: Variation, Renewal etc (Version 1.2)	Final	Application Process, Variations
UK	MHRA	Good clinical practice for clinical trials	Final	Procedural, Clinical Trials
US	FDA	Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers	Draft	Biologics, Biosimilars, Variations
US	FDA	Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment - Guidance for Industry	Draft	Pediatrics, Clinical, Medical
US	FDA	Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products - Guidance for Industry and FDA Staff	Draft	Combination Products, Safety
US	FDA	Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers- Guidance for Industry	Draft	Advertising
US	FDA	ICH M12 Drug Interaction Studies - Guidance for Industry	Final	Clinical Pharmacology
US	FDA	ICH M12 Drug Interaction Studies Questions and Answers - Guidance for Industry	Final	Clinical Pharmacology
US	FDA	Providing Over-the-Counter Monograph Submissions in Electronic Format - Guidance for Industry	Final	Electronic Submissions
US	FDA	Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products - Guidance for Industry	Final	Clinical Trials, Real World Data, Real World Evidence
US	FDA	Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies - Guidance for Industry	Final	Clinical, Pharmacology
US	FDA	Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older - Guidance for Industry	Final	Pediatrics, Clinical, Pharmacology
US	FDA	Container Closure System and Component Changes: Glass Vials and Stoppers - Guidance for Industry	Final	Pharmaceutical Quality, Manufacturing
US	FDA	Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma - Guidance for Industry	Final	Blood Products
US	FDA	Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry	Final	Blood Products
US	FDA	Application User Fees for Combination Products - Guidance for Industry and FDA Staff	Final	User Fees, Application Process, Combination Products

Global Pharma Guidance Tracker – July 2024

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