Country	Organization	Document	Status	Category
International	WHO	WHO Preferred Product Characteristics (PPC) for Bivalent Salmonella Typhi/Paratyphi A Vaccines	Draft	Vaccines
International	WHO	WHO Salmonella Typhi/Paratyphi A Bivalent Vaccine Research and Development Technology Roadmap	Draft	Vaccines
International	WHO	Target Product Profiles for mpox Vaccines (Version 1)	Draft	Vaccines
International	WHO	Recommended Comparator Products: Influenza-specific Antiviral Medicines	Final	Generics, Product Development, Bioequivalence, Antimicrobial
International	WHO	Notes on the Design of Bioequivalence Study: Abacavir/Lamivudine	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the design of bioequivalence study: Artesunate/Pyronaridine	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Baloxavir marboxil	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Dihydroartemisinin/Piperaquine Tetraphosphate	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Norethisterone Enanthate/Estradiol Valerate	Final	Generics, Product Development, Bioequivalence
International	ICH	E11A Pediatric Extrapolation	Final	Pediatrics, Efficacy
Australia	TGA	Adoption of EMA’s version of ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals (ICH M2(R2); EMA/CPMP/ICH/286/1995)	Final	Safety, Toxicology
Australia	TGA	Adoption of EMA’s version of ICH M3(R2) Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2 ) Q&As; EMA/CHMP/ICH/507008/2011)	Final	Safety, Toxicology
Australia	TGA	Adoption of EMA’s version of ICH Considerations - Oncolytic viruses (EMEA/CHMP/ICH/607698/2008)	Final	Cellular and Gene Therapy, Advanced Therapies
Australia	TGA	Adoption of EMA Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products (EMA/CHMP/BWP/360642/2010 rev. 1)	Final	Biologicals, Blood Products, Product Information
Australia	TGA	Adoption of EMA Guideline on Validation of Immunoassay for the Detection of Antibody to Human Immunodeficiency Virus (Anti-HIV) in Plasma Pools (EMEA/CHMP/BWP/298388/05)	Final	Biologicals
Australia	TGA	Adoption of EMA Guideline on validation of immunoassay for the detection of Hepatitis B virus surface antigen (HBSAG) in plasma pools (EMEA/CHMP/BWP/298390/2005)	Final	Biologicals
Australia	TGA	Adoption of EMA Guideline on virus safety evaluation of biotechnological investigational medicinal products (EMEA/CHMP/BWP/398498/2005)	Final	Biologicals, Safety
Australia	TGA	Adoption of EMA Guideline on xenogeneic cell-based medicinal products (EMEA/CHMP/CPWP/83508/2009)	Final	Cellular and Gene Therapy, Advanced Therapies
Australia	TGA	Adoption of EMA’s version of ICH Considerations - General Principles to Address Virus and Vector Shedding (EMEA/CHMP/ICH/449035/2009)	Final	Cellular and Gene Therapy, Advanced Therapies
Australia	TGA	Adoption of EMA’s version of ICH E12 Principles for clinical evaluation of new antihypertensive drugs (ICH E12; CPMP/ICH/541/00)	Final	Clinical, Medical, Efficacy
Australia	TGA	Adoption of EMA’s version of ICH guideline E14 - the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) – questions and answers (EMA/CHMP/ICH/310133/2008)	Final	Efficacy, Safety
Australia	TGA	Adoption of EMA’s version of ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER) (ICH E2C (R2); EMA/CHMP/ICH/544553/1998)	Final	Efficacy, Pharmacovigilance, Safety
Australia	TGA	Adoption of EMA’s version of ICH guideline E3 - questions and answers (R1) (ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012)	Final	Efficacy
Australia	TGA	Adoption of EMA’s version of ICH guideline E8 (R1) on general considerations for clinical studies (ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr)	Final	Efficacy, Clinical Trials
Australia	TGA	Adoption of EMA’s version of ICH topic E3 - Note for guidance on structure and content of clinical study reports (ICH E3; CPMP/ICH/137/95)	Final	Efficacy, Clinical Trials
Australia	TGA	Adoption of EMA Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products (EMA/CHMP/BWP/814397/2011)	Final	Biologicals, Safety
Australia	TGA	Adoption of EMA Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products (EMA/CHMP/BWP/429241/2013)	Final	Biologicals, Manufacturing, GMP
Australia	TGA	Adoption of EMA Guideline on the replacement of rabbit pyrogen testing by an alternative test for plasma-derived medicinal products (EMEA/CHMP/BWP/452081/2007)	Final	Biologicals, Blood Products
Australia	TGA	Adoption of EMA Guideline on the requirements for clinical documentation for orally inhaled products (OIP) Including requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev.1)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population (EMEA/CHMP/EWP/147013/2004 Corr)	Final	Pediatrics, Clinical Pharmacology
Australia	TGA	Adoption of EMA Guideline on the scientific data requirements for a plasma master file (PMF) revision 1 (EMEA/CHMP/BWP/3794/03 Rev.1)	Final	Biologicals, Blood Products
Australia	TGA	Adoption of EMA Guideline on the Scientific Data Requirements for a Vaccine Antigen Master File (VAMF) (EMEA/CPMP/BWP/3734/03)	Final	Vaccines, Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (EMA/CHMP/CVMP/QWP/850374/2015)	Final	Quality
Australia	TGA	Adoption of EMA Guideline on the treatment of premenstrual dysphoric disorder (PMDD) (EMA/CHMP/607022/2009)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products (EMA/CHMP/BWP/457920/2012 rev 1)	Final	Biologicals, Safety
Australia	TGA	Adoption of EMA Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009)	Final	Efficacy, Clinical Pharmacology
Australia	TGA	Adoption of EMA Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products (EMA/CHMP/594085/2015)	Final	Efficacy, Clinical Pharmacology, Bioequivalence, Antimicrobial
Australia	TGA	Adoption of EMA Guideline on the quality of transdermal patches (EMA/CHMP/QWP/608924/2014)	Final	Quality
Australia	TGA	Adoption of EMA Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (EMA/CAT/80183/2014)	Final	Cellular and Gene Therapy, Advanced Therapies
Australia	TGA	Adoption of EMA Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications (EMEA/CHMP/SWP/169215/2005)	Final	Pediatrics, Toxicology
Australia	TGA	Adoption of EMA Guideline on the non-clinical development of fixed combinations of medicinal products (EMEA/CHMP/SWP/258498/2005)	Final	Safety, Pharmacology
Australia	TGA	Adoption of EMA Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products (EMEA/CHMP/GTWP/125459/2006)	Final	Toxicology, Cellular and Gene Therapy, Advanced Therapies
Australia	TGA	Adoption of EMA Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CHMP/EWP/280/96 Corr 1)	Final	Efficacy, Safety, Clinical pharmacology
Australia	TGA	Adoption of EMA Guideline on the quality of biological active substances produced by stable transgene expression in higher plants (EMEA/CHMP/BWP/48316/2006)	Final	Biologicals, Quality
Australia	TGA	Adoption of EMA Guideline on the development of medicinal products for the treatment of post-traumatic stress disorder (PTSD) (CHMP/EWP/358650/2006 Corr 2)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the development of medicinal products for the treatment of smoking (CHMP/EWP/369963/05)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the development of new medicinal products for the treatment of Crohn's disease (CPMP/EWP/2284/99 Rev. 1)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the development of new medicinal products for the treatment of ulcerative colitis (CHMP/EWP/18463/2006)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of control samples in nonclinical safety studies: Checking for contamination with the test substance (CPMP/SWP/1094/04)	Final	Toxicology, Safety
Australia	TGA	Adoption of EMA Guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease (EMA/CHMP/EWP/342691/2009)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of medicinal products for cardiovascular disease prevention (EMEA/CHMP/EWP/311890/2007)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing (EMA/CHMP/336243/2013)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome (CPMP/EWP/785/97 Rev. 1)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CPMP/EWP/552/95 Rev. 2)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2)	Final	Clinical, Medical
Australia	TGA	Adoption of EMA Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function (EMA/83874/2014)	Final	Efficacy, Safety, Clinical Pharmacology
Australia	TGA	Adoption of EMA Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function (CPMP/EWP/2339/02)	Final	Efficacy, Safety, Clinical Pharmacology
Australia	TGA	Adoption of EMA Guideline on the exposure to medicinal products during pregnancy: Need for post authorisation data (EMEA/CHMP/313666/2005)	Final	Safety, Pharmacovigilance
Australia	TGA	Adoption of EMA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr)	Final	Clinical Pharmacology, Bioequivalence
Australia	TGA	Adoption of EMA Guideline on the investigation of drug interactions (CPMP/EWP/560/95/Rev. 1 Corr)	Final	Efficacy, Safety, Clinical Pharmacology
Australia	TGA	Adoption of EMA Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to vCJD risk (CPMP/BWP/CPMP/5136/03)	Final	Biologicals, Blood Products, Safety, Manufacturing
Australia	TGA	Adoption of EMA Guideline on the investigation of medicinal products in the term and preterm neonate (EMEA/536810/2008)	Final	Pediatrics, Efficacy, Safety
Australia	TGA	CTA scheme forms	Final	Clinical Trials
Australia	TGA	Form - Application to amend the Poisons Standard	Final	Product Classification, Procedural
Australia	TGA	Should your product be in the ARTG	Final	Product Classification, Procedural
Canada	HC	Guidance Document: Certificates of Supplementary Protection	Final	Intellectual Property, Procedural
Canada	HC	Guidance Document: Switching from prescription to nonprescription status	Final	Switching
Denmark	DMA	Q&A about package leaflets and labelling	Final	Product Information, Labeling
Denmark	DMA	Stocks of critical medicines	Final	Supply, Distribution, Compliance
Egypt	EDA	Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority (Version 3)	Draft	Clinical Trials
Egypt	EDA	Guideline for Lot Release of Biological Products in Egypt (Version 2)	Draft	Biologicals, Manufacturing, GMP, Quality
Egypt	EDA	Requirement for post approval stability studies submission (Shelf-Life Extension/Change In-Use Study/Change in Stability Storage Conditions), Version 1	Final	Manufacturing, GMP, Quality, Variations
Egypt	EDA	General Administration of Stability – FAQ (Version 1)	Final	Manufacturing, GMP, Quality, Variations
Egypt	EDA	Guidance for File Content of Stability study dossier (Version 1)	Final	Manufacturing, GMP, Quality, Variations
EU	EMA	Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling (EMA/CHMP/170670/2024)	Draft	Safety, Pharmacovigilance, Labeling
EU	EMA	Product Lifecycle Management Portal – Human Variations eAF: Guide to navigation (Version 1.5)	Draft	Variations, Electronic Submissions
EU	EMA	EudraCT & EU CTR Frequently asked questions (Version 2.4)	Final	Clinical Trials
EU	EMA	Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities	Final	Artificial Intelligence, Machine Learning
EU	EMA	Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status (SOP/EMA/0039)	Final	Procedural, Administrative
EU	EMA	Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status (SOP/EMA/0124)	Final	Procedural, Administrative
EU	EMA	Acceptable intakes (AIs) established for N-nitrosamines: Appendix 1 to 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/393815/2024/Rev. 6)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
EU	EMA	Form - Rapid alert notification of a quality defect/recall	Final	Safety, Pharmacovigilance, Compliance
EU	EMA	Form - Follow-up and non-urgent information for quality defects	Final	Safety, Pharmacovigilance, Compliance, Quality
EU	EMA	Form - Sponsor’s report on the maintenance of designation criteria at the time of MA or type II variation application for a designated orphan medicinal product	Final	Procedural, Application Process, Inspections, Orphans, Rare Diseases
EU	EMA	ICH E11A Guideline on pediatric extrapolation - Step 5 (EMA/CHMP/ICH/205218/2022)	Final	Pediatrics, Efficacy
EU	EMA	Management of rapid alerts arising from quality defects risk assessment	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Good manufacturing practice (GMP) inspection report – Union format	Final	Manufacturing, GMP, Inspections, Compliance
EU	EMA	Clinical Trials Information System (CTIS) - Sponsor Handbook (Version 4.0)	Final	Clinical Trials, Procedural
EU	EMA	Guide to CTIS Training Catalogue - CTIS Training Programme (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Quick guide: Transitional trials from EudraCT to CTIS (sponsor users) - CTIS Training Programme: Module 23 (Version 1.4)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: Transitional trials from EudraCT to CTIS - CTIS Training Programme: Module 23 (Version 1.4)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: Supervise a CT – Ad Hoc Assessment - CTIS Training Programme: Module 17 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Instructor’s Guide: Supervise a CT – Ad Hoc Assessment - CTIS Training Programme: Module 17 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Step-by-step guide: Supervise a CT – Ad Hoc Assessment - CTIS Training Programme: Module 17 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: How to create, submit and withdraw a CTA - CTIS Training Programme: Module 10 (Version 1.6)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: How to manage a clinical trial - Notifications, Ad hoc assessment, Corrective measures and Trial results - CTIS Training Programme: Module 05 (Version 1.4)	Final	Clinical Trials, Procedural
EU	EMA	IRIS guide for applicants (How to create, submit and manage IRIS applications, for industry and individual applicants) (EMA/444925/2018), Version 3.3	Final	Procedural, Application Process, Inspections, Orphans, Rare Diseases
EU	EMA	EMA guidance document on the use of medicinal products for treatment and prophylaxis in case of exposure to biological agents used as weapons of terrorism, crime or warfare (EMA/323691/2024)	Final	Clinical, Safety, Antimicrobial
EU	EMA	EMA guidance document on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare (EMA/323692/2024)	Final	Clinical, Safety
EU	EMA	Product Management Service (PMS) – Frequently Asked Questions (FAQs)	Final	Procedural, Application Process, Product Information, Pharmacovigilance, Safety
EU	EMA	Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages (EMA/670900/2020 Rev 16)	Final	Procedural, Product Information, Labeling, Supply
EU	EMA	Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products (EMA/670966/2020 Rev 7)	Final	Labeling, Packaging, Procedural
EU	EMA	Member states contact points for review of national versions of the content of mobile scanning and other technologies (EMA/358267/2015 Rev. 12)	Final	Procedural, Product Information
Ghana	FDA	Guidelines for registration of human vaccines (Published August 2024)	Final	Application Process, Vaccines
Ghana	FDA	Guidelines for Reporting Variations to a Registered Biological Product (Published August 2024)	Final	Variations, Biologicals
Ghana	FDA	Guideline for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Ghana (Published August 2024)	Final	Clinical Trials
Ghana	FDA	Guideline for Conduct of Clinical Trials During Emergencies (Published August 2024)	Final	Clinical Trials
Ghana	FDA	Guideline for Conduct of Clinical Trials in Paediatric Population (Published August 2024)	Final	Clinical Trials, Pediatrics
Ghana	FDA	Guideline for Good Clinical Practice in Ghana (Published August 2024)	Final	Clinical Trials
Ghana	FDA	Guidelines on the Content and Procedure for Development and Publication of Public Assessment Reports for Clinical Trial Applications (Published August 2024)	Final	Clinical Trials
Ghana	FDA	Guideline on Donation of Drugs (Published August 2024)	Final	Quality, Safety
Ghana	FDA	Guideline on Conducting Bioequivalence Studies (Published August 2024)	Final	Clinical Pharmacology, Bioequivalence
Ghana	FDA	Guideline on Importation of Drugs (Published August 2024)	Final	Trade, Quality
Ghana	FDA	Guideline on the Registration of Parallel Imported Medicinal Products (Published August 2024)	Final	Trade, Supply
Ghana	FDA	Guideline on Registration of Allopathic Drugs (Published August 2024)	Final	Application Process
Ghana	FDA	Guideline on Registration of Allopathic Drugs – Quality Part (Published August 2024)	Final	Application Process, Quality
Ghana	FDA	Guideline on Emergency Use Authorization of Medical Products (Published August 2024)	Final	Procedural, Application Process
Ghana	FDA	Guidelines on FDA Public Assessment Report (Published August 2024)	Final	Procedural
Ghana	FDA	Guideline on Labelling of Drugs (Published August 2024)	Final	Labeling
Ghana	FDA	Guideline on Naming of Medicinal Products (Published August 2024)	Final	Procedural, Application Process
Ghana	FDA	Guideline on Registration of Allopathic Medicines Considered for Small Scale manufacture (Published August 2024)	Final	Application Process
Ghana	FDA	Guideline on Registration of Orphan Drugs (Published August 2024)	Final	Application Process, Orphans, Rare Diseases
Ghana	FDA	Guideline on Registration of UK Generics (Published August 2024)	Final	Application Process, Generics
Ghana	FDA	Guideline on Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products (Published August 2024)	Final	Quality, Manufacturing, GMP
Ghana	FDA	Guideline on the Registration of Medicinal Products Classified for Fast Track Processing (Published August 2024)	Final	Application Process
Ghana	FDA	Guideline on Withdrawal, Suspension, or Cancellation of Marketing Authorization (Published August 2024)	Final	Safety, Pharmacovigilance
Ghana	FDA	Guideline on Variations (Published August 2024)	Final	Variations
India	CDSCO	Draft Guidelines on Good Distribution Practices for Pharmaceutical Products	Draft	Distribution, Supply, Compliance
India	CDSCO	Implementation of Schedule M and WHO Technical Report Series	Final	Manufacturing, GMP, Quality
India	CDSCO	Specifying names of countries under the Rule 101 of New Drugs and Clinical Trial Rules, 2019 related to new drug approval	Final	Clinical Trials
India	DoP	Data format in respect of Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024	Final	Promotion, Advertising, Compliance
Italy	AIFA	Guideline on regulatory simplification and elements of decentralisation for conducting clinical trials of medicines	Final	Clinical Trials
Italy	AIFA	Guideline for the classification and conduct of observational studies on medicines	Final	Safety, Pharmacovigilance, Real World Data, Real World Evidence
Japan	PMDA	Points to Consider in the Development of in vivo Gene Therapy Products with Target Specificity – Including in vivo CAR-T Development [Provisional Translation]	Final	Cellular and Gene Therapy, Advanced Therapies
Japan	PMDA	Considerations for the Utilization of Master Protocol Trials in Drug Development [Provisional Translation]	Final	Clinical Trials
Malaysia	NPRA	Reliance Pilot - Revision of Categories and Criteria for New/Additional Indication Application	Final	Safety, Pharmacovigilance, Cellular and Gene Therapy, Advanced Therapies
Netherlands	CCMO	Sample ABR form Research Portal	Final	Clinical Trials
Netherlands	CCMO	Briefing Book information - Pilot Scientific Advice CCMO	Final	Clinical Trials
Netherlands	CCMO	Transition to Research Portal	Final	Clinical Trials, Procedural
New Zealand	Medsafe	Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical trials – regulatory approval and good clinical practice requirements (Edition 3.0)	Draft	Clinical Trials
New Zealand	Medsafe	Guideline on the Regulation of Therapeutic Products in New Zealand: Considerations for First-In-Human (FIH) and Early Phase Clinical Trials (Edition 1.0)	Draft	Clinical Trials
New Zealand	Medsafe	Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trial Safety Monitoring and Reporting for Investigational Products (Medicines and Medical Devices) (Edition 1.0)	Draft	Clinical Trials
Nigeria	NAFDAC	NAFDAC Guidelines on Variations to a Registered Pharmaceutical Product	Final	Variations
Nigeria	NAFDAC	Guidelines for Registration Of Drug Products Made In Nigeria (Human And Veterinary Drugs)	Final	Application Process
Pakistan	DRAP	Guidelines on Submission of Expenditure Details Under the Ethical Marketing to Healthcare Professionals Rules, 2021 (PHSR/ GL / DM /013), 1st Edition	Draft	Procedural, Application Process
Pakistan	DRAP	Statutory Regulatory Order (SRO) 1324(l)12024 – Revision of Regulatory Fee Notification	Final	Procedural, Application Process
Philippines	FDA Philippines	Prescribing the Rules and Regulations on the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Intended Solely for Export	Final	Trade, Manufacturing, GMP, Quality
Saudi Arabia	Saudi FDA	Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: Pregnant and breastfeeding women (Version 1.0)	Final	Safety, Pharmacovigilance
Saudi Arabia	Saudi FDA	Templates for Labelling Information, SPC and PIL (Version 1.3)	Final	Product Information, Labeling
Saudi Arabia	Saudi FDA	Integration Guide for Drug Track & Trace System (Version 2.1)	Final	Supply, Distribution, Labeling, Safety, Pharmacovigilance
Saudi Arabia	Saudi FDA	Economic Evaluation Studies Guidelines (Version 1.0)	Final	Compliance, Policy
Singapore	HSA	Common Questions related to generic drug applications	Final	Generics
Singapore	HSA	Post-Marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (Version 4.1)	Final	Safety, Pharmacovigilance, Cellular and Gene Therapy, Advanced Therapies
South Africa	SAHPRA	Communication - Quality Variations	Final	Variations, Procedural
South Africa	SAHPRA	Form - Sameness declaration form for reliance-based models	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document - Authorisation of human medicinal product with new active substance (Version 2.0)	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document - Authorisation of human medicinal product with known active substance (Version 6.0)	Final	Procedural, Application Process
Switzerland	Swissmedic	Form - New authorisation of human medicinal products (Version 10)	Final	Procedural, Application Process
Switzerland	Swissmedic	Form - Mobile technologies	Final	Product Information, Packaging, Labeling
Switzerland	Swissmedic	Information sheet - Combined studies (Version 1.0)	Final	Clinical Trials, Companion Diagnostics
Switzerland	Swissmedic	Form - Authorisation combined study IMP and MD	Final	Clinical Trials
Switzerland	Swissmedic	Form - Authorisation combined study IMP and IVD	Final	Clinical Trials, Companion Diagnostics
Switzerland	Swissmedic	Form - Combined study MP/ATMP and MD/IVD Amendments, notifications, reports	Final	Clinical Trials
Switzerland	Swissmedic	Form - Notification of safety measures combined studies	Final	Clinical Trials
Switzerland	Swissmedic	Form - Application Confidentiality Restrictions	Final	Clinical Trials
Switzerland	Swissmedic	Information sheet - Swissmedic eGov Portal Standard functions (Version 4.4)	Final	Procedural, Application Process, Administrative
Switzerland	Swissmedic	Information sheet - Swissmedic Portal standard functions: Questions and answers (Version 4.5)	Final	Procedural, Application Process, Administrative
Switzerland	Swissmedic	Guidance document - Time limits for authorisation applications (Version 8.0)	Final	Procedural, Application Process
Switzerland	Swissmedic	Responsible Person: requirements (Version 7.0)	Final	Manufacturing, GMP, Quality, Compliance, Procedural
Switzerland	Swissmedic	Form - Terms of use Master (Clinical Trials) CT contract (Version 1.1)	Final	Clinical Trials
Switzerland	Swissmedic	Form - Decision minutes Accelerated Application Hearing (Version 4.0)	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document - No marketing/interruption of distribution (Version 3.0)	Final	Supply, Distribution, Compliance
Switzerland	Swissmedic	Form - No marketing/interruption of distribution (Version 2.0)	Final	Supply, Distribution, Compliance
Switzerland	Swissmedic	Directory Overview of documents to be submitted (Version 10)	Final	Procedural, Application Process, Administrative
Switzerland	Swissmedic	Information sheet - Guidance for Industry on the electronic exchange of ICSRs in E2B(R2) format through PV Gateway (Version 6.0)	Final	Safety, Pharmacovigilance
Switzerland	Swissmedic	Information sheet - Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway (Version 1.0)	Final	Safety, Pharmacovigilance
Switzerland	Swissmedic	Information sheet - Reporting quality defects in labile blood products (Version 1.0)	Final	Blood Products, Safety, Pharmacovigilance
UK	MHRA	MHRA consultation on statutory fees - Proposals on ongoing cost recovery	Draft	Procedural, Application Process
UK	MHRA	Consultation on 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
UK	MHRA	UK-wide licensing for human medicines	Final	Procedural, Application Process
UK	MHRA	Pharmacovigilance following agreement of the Windsor Framework	Final	Safety, Pharmacovigilance
UK	MHRA	International Recognition Procedure	Final	Application Process, Variations
UK	MHRA	Clinical trials for medicines: apply for authorisation in the UK	Final	Clinical Trials
UK	MHRA	Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland	Final	Trade, Quality, Procedural, Manufacturing, GMP
UK	MHRA	Good laboratory practice (GLP) for safety tests on chemicals	Final	Safety
UK	MHRA	Apply for the early access to medicines scheme (EAMS)	Final	Procedural, Application Process
UK	MHRA	Pre-submission Advice & Support	Final	Procedural, Application Process
UK	MHRA	Medicines Pipeline data	Final	Procedural, Application Process
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
US	FDA	BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment - Guidance for Industry	Draft	Clinical, Medical
US	FDA	Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA - Guidance for Industry	Final	Generics
US	FDA	Bioresearch monitoring technical conformance guide - Technical Specifications Document	Final	Electronic Submissions
US	FDA	Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases - Guidance for Industry	Final	Oncology
US	FDA	FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products - Guidance for Industry: Technical Specifications Document	Final	Efficacy, Safety, Pharmacovigilance
US	FDA	Draft Guidance on Air Polymer-Type A – Intrauterine (Foam)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fezolinetant – Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Heparin Sodium; Taurolidine (Solution)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Leniolisib Phosphate – Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Naloxone Hydrochloride – Nasal (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Nedosiran Sodium – Injection (Solution)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Nirmatrelvir; Ritonavir – Oral (Tablet, Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Pegcetacoplan – Intravitreal (Solution)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Risperidone – Intramuscular (For Suspension, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Sotagliflozin – Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Tafluprost – Ophthalmic (Solution, Drops)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Teriparatide – Subcutaneous (Solution)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Tofersen – Intrathecal (Solution)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Trofinetide – Oral (Solution)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Albuterol Sulfate – Inhalation (Aerosol, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Albuterol Sulfate; Ipratropium Bromide – Inhalation (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Apalutamide – Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Azelaic Acid – Topical (Cream)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Bempedoic Acid; Ezetimibe – Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Budesonide – Inhalation (Powder, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Bupropion Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Carvedilol Phosphate – Oral (Capsule, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Ciprofloxacin Hydrochloride; Hydrocortisone – Otic (Suspension/Drops)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Ciprofloxacin; Dexamethasone – Otic (Suspension/Drops)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Cladribine- Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Dalfampridine – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Dapagliflozin; Metformin Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Donepezil Hydrochloride; Memantine Hydrochloride – Oral (Capsule, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fentanyl Citrate – Nasal (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Ferric Citrate - Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate – Inhalation (Powder)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Propionate – Inhalation (Aerosol, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Propionate – Inhalation (Powder); Strengths: 0.05 mg/inh, 0.1 mg/inh, 0.25 mg/inh	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Propionate – Inhalation (Powder); Strengths: 0.055 mg/inh, 0.113 mg/inh, 0.232 mg/inh	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate – Inhalation (Powder) 0.055 mg/inh; EQ 0.014 mg Base/inh, 0.113 mg/inh; EQ 0.014 mg Base/inh, 0.232 mg/inh; EQ 0.014 mg Base/inh	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate – Inhalation (Aerosol, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate – Inhalation (Powder) 0.1 mg/inh; EQ 0.05 mg Base/inh, 0.25 mg/inh; EQ 0.05 mg Base/inh, 0.5 mg/inh; EQ 0.05 mg Base/inh	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Halobetasol Propionate – Topical (Ointment)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Hydrochlorothiazide; Metoprolol Succinate – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Hydromorphone Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Ibrutinib – Oral (Tablet)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Levalbuterol Tartrate – Inhalation (Aerosol, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Levomilnacipran Hydrochloride – Oral (Capsule, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Memantine Hydrochloride – Oral (Capsule, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Metformin Hydrochloride; Sitagliptin Phosphate – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Metformin Hydrochloride; Saxagliptin Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Mometasone Furoate – Inhalation (Powder)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Morphine Sulfate – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Morphine Sulfate – Oral (Capsule, Extended Release); Strengths: 30 mg, 45 mg, 60 mg, 75 mg, 90 mg, 120 mg	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Morphine Sulfate – Oral (Capsule, Extended Release); Strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 100 mg, 130 mg, 150 mg, 200 mg	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Naloxone Hydrochloride – Nasal (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Olodaterol Hydrochloride – Inhalation (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Olodaterol Hydrochloride; Tiotropium Bromide – Inhalation (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Oxcarbazepine – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Oxymorphone Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Phentermine Hydrochloride; Topiramate – Oral (Capsule, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Posaconazole – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Progesterone – Vaginal (Insert)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Promethazine Hydrochloride – Rectal (Suppository)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Quetiapine Fumarate – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Tacrolimus – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Tapentadol Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Tiotropium Bromide – Inhalation (Spray, Metered)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Tramadol Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Trospium Chloride – Oral (Capsule, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Venlafaxine Hydrochloride – Oral (Tablet, Extended Release)	Draft	Generics, Product Development, Bioequivalence
US	FDA	Draft Guidance on Verteporfin – Injection (Injectable)	Draft	Generics, Product Development, Bioequivalence

Global Pharma Guidance Tracker – August 2024

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