Global Pharma Guidance Tracker – October 2021

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Click on the links to access the documents that have been added to the Pink Sheet's Guidance Tracker over the past month. The complete Global Pharma Guidance Tracker with sortable and searchable listings going back to 2014 is available here.

 

Country	Organization	Document	Status	Category
International	WHO	WHO manual for the establishment of national and other secondary standards for antibodies against infectious agents focusing on SARS CoV2	Draft	Biologics
International	WHO	WHO Guideline for the safe production and quality control of monoclonal antibodies for use in humans	Draft	Biologics, Quality
Australia	TGA	GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic	Final	Manufacturing, GMP, Inspections, Compliance
Australia	TGA	Notice of interim decisions on proposed amendments to the Poisons Standard – Joint ACMS-ACCS #28 – June 2021	Draft	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	Notice of interim decisions on proposed amendments to the Poisons Standard – ACCS #31 – June 2021	Draft	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	Notice of interim decisions on proposed amendments to the Poisons Standard (sodium nitrite) - June 2021	Draft	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	Notice of final decisions to amend (or not amend) the current Poisons Standard in relation to nitrous oxide	Final	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	AIVC recommendations for the composition of influenza vaccine for Australia in 2022	Final	Vaccines
Belgium	FAMHP	Modified invoicing for applications for national scientific-technical advice	Final	Procedural, Administrative, Application Process
Canada	HC	Guidance for market authorization requirements for COVID-19 drugs	Final	Application Process, Product Development
Canada	HC	Release of Draft (Step 2) ICH Guideline: Q13: Continuous Manufacturing of Drug Substances and Drug Products	Draft	Manufacturing, GMP, Quality
Denmark	DMA	Deregistration of medicinal products	Final	Procedural, Administrative
Denmark	DMA	Temporary repackaging of medicines with a marketing authorisation	Final	Packaging, Distribution
Denmark	DMA	Application for variations	Final	Variations, Procedural
EU	EC	Clinical Trials Regulation (EU) No 536/2014: Questions & Answers (Version 4.1)	Draft	Clinical Trials
EU	CMDh	Recommendations on submission dates in 2022 for Applicants of the Mutual Recognition Procedure (MRP) (CMDh/082/2002, Rev.15)	Final	Procedural, Application Process
EU	CMDh	CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (CMDh/412/2019, Rev.13) [Track version]	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality
EU	CMDh	Template: Cover letter for new applications submitted through MRP/DCP (CMDh/226/2007 Rev.9)	Final	Application Process, Procedural
EU	CMDh	CMDh Best Practice Guide on Multilingual Packaging (CMDh/413/2019/Rev. 3) [Track version]	Final	Labeling, Packaging, Distribution
EU	CMDh	Core SmPC for hormone replacement therapy products (CMDh/131/2003, Rev. 8) [Track version]	Final	Product Information
EU	CMDh	Core package leaflet for hormonal replacement therapy products based on core SmPC HRT, revision 8, October 2021(CMDh/240/2011, Rev.6) [Track version]	Final	Product Information
EU	EMA	Guideline on registry-based studies (EMA/426390/2021)	Final	Clinical Trials, Real World Data
EU	EMA	Article 57 User Interface (UI) Installation Guide (EMA/550318/2021)	Final	Procedural, Administrative, Safety, Pharmacovigilance
EU	EMA	Tailored scientific advice to support step-by-step development of new biosimilars (EMA/289230/2021)	Final	Biosimilars, Procedural, Application Process
EU	EMA	Submission form - Repurposing pilot project for authorised medicines	Final	Variations, Procedural, Application Process
EU	EMA	Question and Answers on repurposing pilot project	Final	Variations, Procedural, Application Process
EU	EMA	eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual – (Version 5.6) (EMA/308954/2012)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 93)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Compilation of Union Procedures on Inspections and Exchange of Information (EMA/INS/428126/2021 Rev 18)	Final	Manufacturing, GMP, Compliance, Inspections
EU	EMA	New product information wording – Extracts from PRAC recommendations on signals – Part 2 Adopted at the 27-30 September 2021 PRAC (EMA/PRAC/548106/2021)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	New product information wording – Extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC (EMA/PRAC/380228/2021 Corr)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	Explanatory note on general fees payable to the European Medicines Agency	Final	Application Process, Procedural
EU	EMA	Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD) - Extended EudraVigilance Medicinal Product Report (XEVPRM) user guidance for sponsors of clinical trials (Version 1) (EMA/186412/2021)	Final	Clinical Trials, Procedural
EU	EMA	Electronic submission of investigational medicinal product (IMP) data to the Extended EudraVigilance medicinal product dictionary (XEVMPD) - Frequently asked questions & answers (Version 1.0) (EMA/157035/2021)	Final	Clinical Trials, Procedural
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.6)	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	EMA	Guide to information on human medicines evaluated by EMA - What the Agency publishes and when (EMA/587373/2021 Rev2)	Final	Procedural, Administrative
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.108)	Final	Safety, Pharmacovigilance
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/579235/2021)	Final	Product Information, Procedural
EU	EMA	Qualification Opinion of IMI PREFER (on Patients Preference studies) (EMADOC-1700519818-732587)	Draft	Product Development, Clinical Trials
EU	EMA	ICH guideline E8 (R1) on general considerations for clinical studies - Step 5 (EMA/CHMP/ICH/544570/1998)	Final	Efficacy, Clinical Trials
EU	EMA	Principles for Sponsor organisation modelling for CTIS – version 1 (EMA/527655/2021)	Final	Clinical Trials, Procedural
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.39)	Final	Procedural, Compliance, Administrative
EU	EMA	Step-by-step guide: Assess an annual safety report - CTIS Training Programme: Module 20 (Version 1.1)	Final	Clinical Trials, Procedural
EU	EMA	Instructor’s Guide: Assess an annual safety report - CTIS Training Programme: Module 20 (Version 1.1)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: Assess an annual safety report - CTIS Training Programme: Module 20 (Version 1.1)	Final	Clinical Trials, Procedural
EU	EMA	CTIS User Personas	Final	Clinical Trials, Procedural
EU	EMA	Template or form: Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified	Final	Clinical Trials, Pediatrics, Procedural
EU	EMA	Member states contact points for translations review (EMA/102302/2005 v. 6.19)	Final	Procedural
EU	EMA	ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – addendum: Step 2b (EMA/CHMP/ICH/272147/2021)	Draft	Safety
Ghana	Ghana FDA	Regulatory Requirement For Anti-Snake Venom Serum (FDA/SMC/BPD/POL-SAV/2021/11)	Final	Biologics, Procedural, Application Process
Hong Kong	DoH	Call for comment: Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products	Draft	Manufacturing, GMP
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Azelaic acid	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Diprophylline	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Trospium chloride	Final	Labeling, Compliance, Prescribing
Japan	PMDA	Guidance on Patient Participation	Final	Procedural
Japan	PMDA	Guidelines for Bioequivalence Studies of Generic Products	Final	Bioequivalence, Clinical Trials, Efficacy, Generics
Malaysia	NPRA	Guideline For Registration of Drug-Medical Device And Medical Device-Drug Combination Products (4th Edition)	Final	Combination Products
Netherlands	CCMO	New directive makes use of Site Suitability Declaration (VGO) obligatory for research with a medicinal product as of 1 November 2021	Final	Clinical Trials, Procedural
Norway	NoMA	Information regarding changes to Clinical Trial Application processing times	Final	Clinical Trials, Procedural
Pakistan	DRAP	Imports & Exports of Therapeutic Goods - 1^st Edition (QALT/GL/IP/004)	Draft	Trade, Supply, Procedural
Pakistan	DRAP	Establishment of Pharmaceutical Unit and Post License Changes - 1^st Edition (DLIC/GL/LC/001)	Draft	Manufacturing, GMP, Variations, Procedural
Pakistan	DRAP	SRO 1347(I)/2021 (Notification Regarding Amendments in Rule 20A and Schedule-H of the Drugs (Licensing, Registering and Advertising) Rules,1976 Pertaining to Contract Manufacturing.)	Final	Manufacturing, GMP
Pakistan	DRAP	Checklist for Evaluation of application for Issuance of cGMP Certificate	Final	Manufacturing, GMP, Procedural
Philippines	FDA Philippines	Revised Guidelines on Good Manufacturing Practice (GMP) Clearance for Foreign Drug Manufacturers	Draft	Manufacturing, GMP, Compliance, Inspections
Saudi Arabia	Saudi FDA	The GCC Guidelines for Bioequivalence (version 3.0)	Final	Bioequivalence, Clinical Trials, Efficacy, Generics
Saudi Arabia	Saudi FDA	Regulatory Framework for Drugs Approval (Version 6.2)	Final	Application Process, Procedural
South Africa	SAHPRA	Post-marketing reporting of adverse drug reactions to human medicines in South Africa (Version 9.0)	Final	Safety, Pharmacovigilance
South Africa	SAHPRA	Reliance Guideline (Version 2.0)	Final	Application Process, Variations, Procedural
South Africa	SAHPRA	Safety Reporting During Clinical Trials in South Africa (Version 4)	Final	Clinical Trials, Safety
South Africa	SAHPRA	Re-submission of Business as Usual (BAU) New Medicine Applications from 2018 and 2019	Final	Procedural, Administrative
South Africa	SAHPRA	General guidance document on quality, safety and efficacy requirements for biological medicines	Draft	Quality, Safety, Efficacy, Biologics, Vaccines
Switzerland	Swissmedic	Decentralised clinical trials (DCTs) with medicinal products in Switzerland (Version 1.1)	Final	Clinical Trials
Switzerland	Swissmedic	Involvement of patient organisation in the review of Patient Information	Final	Product Information
Switzerland	Swissmedic	Out-of-Stock – COVID-19 – Authorisations for the temporary import and distribution of human medicines – Update	Final	Trade, Supply, Distribution
UK	MHRA	Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines	Final	Application Process
UK	MHRA	Clinical trials for medicines: manage your authorisation, report safety issues	Final	Clinical Trials
UK	MHRA	Clinical trials for medicines: apply for authorisation in the UK	Final	Clinical Trials
UK	MHRA	MHRA phase I accreditation scheme	Final	Clinical Trials
UK	MHRA	Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes	Final	Procedural, Application Process, Variations
UK	MHRA	Guidance on pharmacovigilance procedures	Final	Safety, Pharmacovigilance, Procedural
US	FDA	Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act - Draft Guidance for Industry	Draft	Procedural, Administrative
US	FDA	Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide - Guidance for Industry	Final	Procedural, Administrative
US	FDA	Data Standards for Drug and Biological Product Submissions Containing Real-World Data - Guidance for Industry	Draft	Real World Data
US	FDA	Q13 Continuous Manufacturing of Drug Substances and Drug Products - Draft Guidance for Industry	Draft	Manufacturing, GMP, Quality
US	FDA	S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals - Draft Guidance for Industry	Draft	Safety, Toxicology
US	FDA	Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry	Draft	Compounding

Key:

WHO: World Health Organization

TGA: Therapeutic Goods Administration

FAMHP: Federal Agency for Medicines and Health Products

HC: Health Canada

DMA: Danish Medicines Agency

EC: European Commission

CMDh: Coordination Group for Mutual Recognition and Decentralised Procedures – Human

EMA: European Medicines Agency

Ghana FDA: Ghana Food and Drugs Authority

DoH: Department of Health

PMDA: Pharmaceuticals and Medical Devices Agency

NPRA: National Pharmaceutical Regulatory Agency

CCMO: Central Committee on Research Involving Human Subjects

NoMA: Norwegian Medicines Agency

DRAP: Drug Regulatory Authority of Pakistan

FDA Philippines: Food and Drug Administration Philippines

Saudi FDA: Saudi Food & Drug Authority

SAHPRA: South African Health Products Regulatory Authority

Swissmedic: Swiss Agency for Therapeutic Products

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration