Country	Organization	Document	Status	Category
International	WHO	FAQ: Variations to prequalified pharmaceutical products (Rev 02)	Final	Variations
International	WHO	Guideline on data integrity (QAS/19.819/Rev.1)	Draft	Safety, Compliance, Inspections
International	WHO	Good reliance practices in regulatory decision-making: high-level principles and recommendations (QAS/20.851)	Draft	Procedural
International	ICH	ICH M7 Guideline: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Questions and Answers	Draft	Safety
International	ICH	ICH electronic Common Technical Document - eCTD v4.0	Final	Application Process, Procedural
Australia	TGA	Submitting data in the eCTD format (Version 1.0)	Final	Application Process, Procedural
Australia	TGA	Submitting data in the NeeS format (Version 1.0)	Final	Application Process, Procedural
Australia	TGA	GMP clearance code tables guidance: Manufacturing steps (Version 1.0)	Final	Manufacturing
Australia	TGA	TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic	Final	Inspections, Compliance, Manufacturing
Australia	TGA	GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic	Final	Inspections, Compliance, Manufacturing
Australia	TGA	Guidance for TGO 106: Medicines - Standard for Serialisation and Data Matrix Codes (Version 1.0)	Draft	Safety, Labeling, Supply
Australia	TGA	Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry	Final	Supply, Trade, Labeling
Australia	TGA	Form: Special application for consent to supply registered medicines that do not conform with TGO 91	Final	Supply, Trade, Labeling
Australia	TGA	Transition to new GMP requirements for medicinal products: A notice about the implications of adopting the PIC/S Guide to GMP PE009-14 (Version 1.0)	Final	Manufacturing, Safety
Australia	TGA	Fees and charges: summary from 1 July 2020 (Version 1.0)	Final	Application Process, Procedural
Australia	TGA	COVID-19 and eligibility to request consent to supply therapeutic goods that do not comply with the new labelling requirements of TGO 92	Final	Supply, Trade, Labeling
Canada	HC	Border requirements for importing and exporting health products (COVID-19)	Final	Trade, Supply
Canada	HC	Release of draft (step 2) ICH guidance: Q3C(R8): Impurities: Residual solvents	Draft	Quality, Safety
Canada	HC	Confirmation of the mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020	Final	Application Process, Procedural
Canada	HC	Release of draft (step 2) ICH guidance: M7(R2): Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk	Draft	Safety
Denmark	DMA	Extraordinary measures for clinical trials due to COVID-19 (Version 6.0) [Track version]	Final	Clinical Trials
Denmark	DMA	Clinical trials - questions and answers	Final	Clinical Trials
Denmark	DMA	Companies' name and address changes	Final	Procedural, Variations
Denmark	DMA	Requirements for retail suppliers of medical gases	Final	Supply, Procedural
EU	EC	Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic (Revision 3)	Final	Procedural, Compliance, Application Process, Variations, Manufacturing, Labeling, Safety Pharmacovigilance
EU	CMDh	Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008 (CMDh/CMDv/132/2009, Rev.56) [Track version]	Final	Variations
EU	CMDh	CMDh ends the pilot for splitting of procedures (CMDh/354/2017, Rev.7) [Track version]	Final	Procedural
EU	CMDh	Template for submission of an application for a Covid-19 exceptional change management process (ECMP)	Final	Variations, Compliance
EU	CMDh	Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis (CMDh/418/2020, Rev.1) [Track version]	Final	Procedural, Compliance, Application Process, Variations, Manufacturing, Labeling, Safety Pharmacovigilance
EU	EMA	Template for submission of a notification for a Covid-19 exceptional change management process (ECMP)	Final	Variations, Compliance
EU	EMA	EudraCT & EU-CTR Question and Answer table (V1.8)	Final	Clinical Trials
EU	EMA	Clinical Trial Application and Results related documentation	Final	Clinical Trials
EU	EMA	List of signals discussed at PRAC since September 2012 (EMA/PRAC/530804/2013)	Final	Safety, Pharmacovigilance
EU	EMA	Contact details of national competent authorities for requests of translation exemption falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages (EMA/95063/2016 rev. 5)	Final	Procedural
EU	EMA	Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (EMA/158330/2020 Rev. 1)	Final	Clinical Trials
EU	EMA	New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC (EMA/PRAC/311316/2020)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Questions & Answers: Step 2b (EMA/CHMP/ICH/321999/2020)	Draft	Safety
EU	EMA	Lapatinib film-coated tablet 250 mg: Product-specific bioequivalence guidance	Draft	Generics, Product Development
EU	EMA	Procedural advice for post-orphan medicinal product designation activities - Guidance for sponsors (EMA/469917/2018)	Final	Procedural, Orphans, Rare Diseases
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/324847/2020.Corr.1)	Final	Product Information, Procedural
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (EMA/630645/2012 Rev.93)	Final	Safety, Pharmacovigilance
EU	EMA	Procedural advice for orphan medicinal product designation: Guidance for sponsors (EMA/420706/2018 Rev 9)	Final	Application Process, Procedural, Orphans, Rare Diseases
EU	EMA	Emerging safety issues (ESI) contact points at the national competent authority (NCA) level (EMA/425422/2017 Corr. 2)	Final	Safety, Pharmacovigilance
EU	EMA	Scientific guidelines with SmPC recommendations (EMA/813125/2012 rev. 6)	Final	Product Information, Labeling, Procedural, Safety
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 79)	Final	Pharmacovigilance, Safety
EU	EMA	Guideline on good pharmacovigilance practices (GVP) Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 3) (EMA/395730/2012 Rev 3)	Final	Pharmacovigilance, Safety
EU	EMA	Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Addendum I of Module VIII on requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (EMA/261052/2020)	Final	Pharmacovigilance, Safety
EU	EMA	Explanatory note on general fees payable to the European Medicines Agency	Final	Application Process, Procedural
EU	EMA	New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC (EMA/PRAC/257439/2020)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	Dates of 2021 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (EMA/444951/2017)	Final	Procedural, Application Process
EU	EMA	Designated Medical Event (DME) list (EMA/326038/2020)	Final	Safety, Pharmacovigilance, Procedural
EU	EMA	Frequently asked questions (EMA/527628/2011 Rev. 2)	Final	Procedural
EU	EMA	CHMP and Rapporteurs' assessment report template on similarity with name of authorised orphan product (Rev. 06.20)	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures: Revised implementing rules to the Fee Regulation as of 12 June 2020 (EMA/MB/238467/2020 Rev. 1)	Final	Application Process, Procedural
EU	EMA	Abiraterone tablets 250 mg and 500 mg: Product-specific bioequivalence guidance	Draft	Generics, Product Development
EU	EMA	Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance	Draft	Generics, Product Development
EU	EMA	IRIS guide to registration Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration - Version 2.3 (EMA/31242/2019)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	Guidance on remote GCP inspections during the COVID-19 pandemic (EMA/INS/GCP/162006/2020)	Final	Clinical Trials, Inspections, Compliance
EU	EMA	Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (EMA/517840/2015 Rev 2)	Final	Pharmacovigilance, Safety
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.23)	Final	Procedural, Compliance, Administrative
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (EMA/136148/2012, Rev.56)	Final	Pharmacovigilance, Safety
EU	EMA	FDA/EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19	Final	Clinical Trials, Pediatrics
Finland	FIMEA	Notifying shortages in the supply of medicines: Updated forms and advance notification	Final	Supply, Distribution, Procedural
Hong Kong	DoH	Invitation for Using the Pharmaceuticals Licence Application and Movement Monitoring System	Final	Procedural, Application Process
Hong Kong	DoH	Regulatory Control of Skin Antiseptic Products Containing Chlorhexidine	Final	Product Classification, Compliance
Iceland	IMA	Changed procedure for variation approvals in worksharing procedures where EMA is the reference authority	Final	Procedural, Variations
India	CDSCO	Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19	Final	Clinical Trials
India	CDSCO	Draft rules for import of unapproved new drug for compassionate use for treatment of patients by hospitals or and medical institution	Draft	Procedural, Compassionate Use
India	DBT	Rapid Response Regulatory Framework for COVID 19 - Compilation of Notifications	Final	Procedural, Safety, Application Process, Clinical Trials
Japan	PMDA	Guideline for Exposure-Response Analysis of Drugs	Final	Clinical Trials, Safety, Efficacy
Malaysia	NPRA	Guidance Notes for API Information for Product Registration (Version 5.0)	Final	Quality, Safety, Efficacy, Application Process
Netherlands	CCMO	Conditions for (re)starting studies in clinical research units (24 June 2020)	Final	Clinical Trials
Netherlands	IGJ	Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO) (Version 4)	Final	Clinical Trials
New Zealand	Medsafe	Updates to clozapine data sheets and monitoring during covid-19 pandemic	Final	Safety, Pharmacovigilance
Pakistan	DRAP	Conduct of clinical trials during COVID-19 pandemic	Final	Clinical Trials
Philippines	FDA Philippines	Interim Guidelines for the Issuance of Current Good Manufacturing Practice (cGMP) Clearance to Foreign Drug Manufacturers	Draft	Manufacturing, Quality, Inspections, Compliance
Philippines	FDA Philippines	New Normal Operational Guidelines of the Food and Drug Administration (FDA) at the Food and Drug Action Center (FDAC)	Draft	Procedural
Switzerland	Swissmedic	Draft Swissmedic eCTD v4.0 Implementation Guides	Draft	Procedural, Application Process
Switzerland	Swissmedic	Optimisation of labelling phase for human medicinal products	Final	Labeling, Procedural, Product Information
Switzerland	Swissmedic	Joint Guidance of Swissmedic and Swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic (Version 2.2)	Final	Clinical Trials
Tanzania	TMDA	Online system for submission of applications for registration of products, premises, clinical trials and good manufacturing practices (GMP) inspections	Final	Procedural, Application Process, Clinical Trials, GMP, Manufacturing
Tanzania	TMDA	Notice on the Procedure for granting approvals to variations of registered medicinal products following implementation of the current variation guidelines	Final	Procedural, Variations
Uganda	NDA	Extension of the deadline for submission of CTD dossiers for renewal of registration	Final	Procedural, Application Process
UK	MHRA	MHRA phase I accreditation scheme	Final	Clinical Trials
UK	MHRA	Good manufacturing practice and good distribution practice	Final	Manufacturing, Distribution, Supply
UK	MHRA	Apply for the early access to medicines scheme (EAMS)	Final	Application Process, Procedural
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
US	FDA	Development of Anti-Infective Drug Products for the Pediatric Population: Draft Guidance for Industry	Draft	Pediatrics, Clinical, Medical
US	FDA	Risk Evaluation and Mitigation Strategies: Modifications and Revisions: Guidance for Industry	Final	Safety, Pharmacovigilance
US	FDA	Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment	Final	Clinical, Antimicrobial
US	FDA	Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment - Guidance for Industry	Final	Clinical, Antimicrobial
US	FDA	Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry	Final	Manufacturing
US	FDA	Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency: Guidance for Industry	Final	Clinical Trials
US	FDA	Patient-Focused Drug Development: Collecting Comprehensive and Representative Input: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders	Final	Procedural
US	FDA	Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry	Final	Vaccines
US	FDA	Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency: Guidance for Industry	Final	Clinical, Medical, Prescription Drugs
US	FDA	Draft Guidance on Abiraterone Acetate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Amoxicillin	Draft	Generics, Product Development
US	FDA	Draft Guidance on Aprepitant	Draft	Generics, Product Development
US	FDA	Draft Guidance on Brexanolone	Draft	Generics, Product Development
US	FDA	Draft Guidance on Buprenorphine	Draft	Generics, Product Development
US	FDA	Draft Guidance on Desvenlafaxine	Draft	Generics, Product Development
US	FDA	Draft Guidance on Dolutegravir Sodium; Lamivudine	Draft	Generics, Product Development
US	FDA	Draft Guidance on Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Estradiol	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fish Oil Triglycerides	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fluorometholone	Draft	Generics, Product Development
US	FDA	Draft Guidance on Gilteritinib Fumarate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Glycopyrrolate; Indacaterol Maleate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ivosidenib	Draft	Generics, Product Development
US	FDA	Draft Guidance on Latanoprost	Draft	Generics, Product Development
US	FDA	Draft Guidance on Metformin Hydrochloride	Draft	Generics, Product Development
US	FDA	Draft Guidance on Methylphenidate Hydrochloride- 85 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Methylphenidate Hydrochloride- 100 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Metronidazole	Draft	Generics, Product Development
US	FDA	Draft Guidance on Prucalopride Succinate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Revefenacin	Draft	Generics, Product Development
US	FDA	Draft Guidance on Sodium Zirconium Cyclosilicate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tafenoquine Succinate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Talazoparib Tosylate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin	Draft	Generics, Product Development
US	FDA	Draft Guidance on Triclabendazol	Draft	Generics, Product Development
US	FDA	Draft Guidance on Albendazole	Draft	Generics, Product Development
US	FDA	Draft Guidance on Azelastine Hydrochloride; Fluticasone Propionate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Buprenorphine	Draft	Generics, Product Development
US	FDA	Draft Guidance on Carglumic Acid	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clindamycin Phosphate (Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clindamycin Phosphate (Swab)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clindamycin Phosphate (Gel)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clindamycin Phosphate (Aerosol)	Draft	Generics, Product Development
US	FDA	Clindamycin Phosphate; Tretinoin	Draft	Generics, Product Development
US	FDA	Draft Guidance on Dapagliflozin	Draft	Generics, Product Development
US	FDA	Draft Guidance on Dapagliflozin; Saxagliptin Hydrochloride	Draft	Generics, Product Development
US	FDA	Draft Guidance on Desvenlafaxine	Draft	Generics, Product Development
US	FDA	Draft Guidance on Desvenlafaxine Fumarate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Desvenlafaxine Succinate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Dihydroergotamine Mesylate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Diltiazem Hydrochloride - 120 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Diltiazem Hydrochloride - 240 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Diltiazem Hydrochloride - 360 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Diltiazem Hydrochloride - 420 mg (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Diltiazem Hydrochloride- 420 mg (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Everolimus	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ferric Citrate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fluticasone Furoate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fluticasone Propionate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Methylphenidate Hydrochloride – 60 mg (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Methylphenidate Hydrochloride – 20 mg (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Metoprolol Tartrate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Metronidazole	Draft	Generics, Product Development
US	FDA	Draft Guidance on Mometasone Furoate	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin (Gel)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin - 0.02% (Cream)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin - 0.04%, 0.06%, 0.08% or 0.1% (Gel)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin - 0.05% (Cream)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin - 0.025% (Cream)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin - 0.05% (Gel)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tretinoin - 0.1% (Cream)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Triamcinolone Acetonide	Draft	Generics, Product Development

Global Pharma Guidance Tracker – June 2020

More from Global Pharma Guidance Update

More from Regulatory Trackers