Global Pharma Guidance Tracker – July 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	Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations (WHO/BS/2021.2402)	Draft	Product Development, Vaccines
International	WHO	Regulatory guidance for assessment and management of applications for marketing authorization of oxytocin	Final	Clinical, Medical, Application Process
International	WHO	IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products (QAS/21.878/Rev1)	Draft	GMP, Manufacturing
International	WHO	WHO good manufacturing practices for medicinal gases (QAS/21.875/Rev1)	Draft	GMP, Manufacturing
International	WHO	WHO good practices for research and development facilities of pharmaceutical products (QAS/20.865/.Rev1)	Draft	Manufacturing, GMP, Quality, Safety
International	WHO	WHO good manufacturing practices for investigational products (QAS/20.863/Rev1)	Draft	Manufacturing, GMP, Clinical Trials
International	ICH	Q13: Continuous manufacturing of drug substances and drug products	Draft	Manufacturing, GMP, Quality
International	PIC/S	COVID-19 risk assessment for routine on-site inspections (PI 055-1)	Final	Inspections, Compliance
International	PIC/S	PIC/S Recommendation - How to evaluate and demonstrate the effectiveness of the pharmaceutical quality system with regard to risk-based change management (PI 054-1)	Final	Quality, Manufacturing, GMP
Australia	TGA	Proposed changes to requirements for listed medicine ingredients: Annual low-negligible risk changes 2021-2022	Draft	Safety, Labeling
Australia	TGA	Streamlining proprietary ingredient categories	Final	Procedural, Manufacturing, GMP
Belgium	FAMHP	End of submissions for initial CTR pilot files on 14 October 2021	Final	Clinical Trials
Belgium	FAMHP	Guidance for submission of dossiers to the Research and Development Division	Final	Clinical Trials
Canada	HC	Management of Drug Submissions and Applications	Final	Application Process
Canada	HC	Classification of products at the drug-medical device interface	Final	Combination Products, Product Classification
Canada	HC	Classification of products under the Food and Drugs Act (F&DA)	Final	Product Classification
Canada	HC	Notice: Clarifications Regarding Access to Restricted Drugs through the Special Access Program (SAP)	Final	Compassionate Use, Prescribing
EU	CMDh	Chapter 6 - CMDh Best Practice Guide for the processing of grouped applications in the Mutual Recognition Procedure (CMDh/296/2013 Rev. 24) [Track version]	Final	Procedural, Variations
EU	CMDh	CMDh Questions & Answers on implementation of outcome of Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (CMDh/400/2019, Rev.4) [Track version]	Final	Quality, Safety, Pharmacovigilance, Efficacy, Variations, Manufacturing, GMP
EU	CMDh	CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008	Final	Variations
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.12) [Track version]	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	CMDh	Template: Request for RMS in a decentralised procedure for medicinal products for human use (CMDh/036/2009, Rev.2)	Final	Procedural, Application Process
EU	CMDh	CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product (CMDh/313/2014, Rev.9) [Track version]	Final	Product Information, Labeling
EU	EMA	Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (EMA/CAT/CHMP/158266/2021)	Draft	Product Information; Labeling, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/419517/2021)	Final	Manufacturing, GMP
EU	EMA	ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b (EMA/CHMP/ICH/427817/2021)	Draft	Quality, Manufacturing, GMP
EU	EMA	Template or form: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification (EMA/343883/2021)	Final	Clinical Trials, Procedural
EU	EMA	Template or form: Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification (EMA/380784/2021)	Final	Clinical Trials, Procedural
EU	EMA	Template or form: Clinical Trial Information System (CTIS) structured data form – Notifications (EMA/297654/2021)	Final	Clinical Trials, Procedural
EU	EMA	Clinical Trial Information System (CTIS) - Sponsor handbook (EMA/299895/2021, V. 1.0)	Final	Clinical Trials, Procedural
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 91)	Final	Pharmacovigilance, Safety
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.105)	Final	Safety, Pharmacovigilance
EU	EMA	Clinical pharmacology and pharmacokinetics: questions and answers	Final	Quality, Safety, Efficacy
EU	EMA	Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017)	Final	Quality, Generics, Biosimilars
EU	EMA	List of substances and products subject to worksharing for signal management (EMA/563056/2014 Rev. 10)	Final	Safety, Pharmacovigilance
EU	EMA	EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines (EMA/213341/2020 Rev.2)	Final	Application Process, Procedural, Product Development, Vaccines
EU	EMA	SWP response to CMDh questions on chlorobutanol (EMA/CHMP/SWP/482438/2020 corr. 1)	Final	Safety, Quality, GMP, Manufacturing
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev. 93) [Track version]	Final	Procedural, Safety, Pharmacovigilance, Variations
EU	EMA	European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (EMA/821278/2015) [Track version]	Final	Procedural, Application Process
EU	EMA	IRIS guide for applicants (how to create and submit scientific applications, for industry and individual applicants) Version 2.1 (EMA/444925/2018)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	Guideline on quality documentation for medicinal products when used with a medical device (EMA/CHMP/QWP/BWP/259165/2019)	Final	Quality, Combination Products
EU	EMA	Draft EU Common Standard for electronic product information for human medicines (ePI) (EMA/319183/2021 Rev. 1)	Draft	Product Information, Labeling
EU	EMA	Explanatory note on general fees payable to the European Medicines Agency as of 15 July 2021	Final	Application Process, Procedural
EU	EMA	Guidance on paediatric submissions via eSubmission Gateway and eSubmission Web Client (EMA/672643/2017 Rev. 4)	Final	Pediatrics, Procedural, Clinical Trials
EU	EMA	Paediatric investigation plans: questions and answers	Final	Pediatrics, Procedural, Clinical Trials
EU	EMA	Consideration on core requirements for PSURs of COVID-19 vaccines (EMA/362988/2021)	Final	Safety, Pharmacovigilance, Vaccines
EU	EMA	Step-by-step guide: Supervise a CT - Ad Hoc Assessment - CTIS Training Programme: Module 17 (Version 1.1)	Final	Clinical Trials, Procedural
EU	EMA	Instructor's guide: Supervise a Clinical Trial: Ad Hoc Assessment - CTIS Training Programme - Module 17 (Version 1.1)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: Supervise a Clinical Trial: Ad Hoc Assessment - CTIS Training Programme - Module 17 (Version 1.1)	Final	Clinical Trials, Procedural
Finland	FIMEA	Instructions for giving a shortage notification	Final	Supply, Distribution, Procedural
Finland	FIMEA	Frequently Asked Questions: Shortage notification	Final	Supply, Distribution, Procedural
Hong Kong	DoH	New licensing condition for Wholesale Dealer Licence (Effective from 1 August 2021 upon licence renewal)	Final	Cellular and Gene Therapy, Advanced Therapies, Procedural, Trade, Supply
Hong Kong	DoH	New Licensing Conditions of Licence for Manufacturer (Effective from 1 August 2021 upon Licence Issuance or Renewal)	Final	Cellular and Gene Therapy, Advanced Therapies, Procedural, Manufacturing
Hong Kong	DoH	Manufacture of Unregistered Pharmaceutical Product for Treatment of Particular Patients (Version 1.0)	Final	Manufacturing, GMP
Hong Kong	DoH	Pharmaceutical products Recall Guidelines	Final	Safety, Pharmacovigilance, Procedural
Hong Kong	DoH	Inspection of Manufacturers of Pharmaceutical Products	Final	Compliance, Inspections
Hong Kong	DoH	Guidance on Application for Licence for Manufacturer of Pharmaceutical Products	Final	Application Process, Procedural
Hong Kong	DoH	Guidance on Application for Licence for Manufacturer Pharmaceutical Product (Secondary Packaging)	Final	Application Process, Procedural, Trade
Hong Kong	DoH	Request for permission of manufacture of unregistered pharmaceutical product by licensed manufacturer for treatment of particular patients	Final	Procedural, Manufacturing, Compassionate Use
Hong Kong	DoH	Guidance on Application for Change of Key Personnel and Manufacturing Premises of Pharmaceutical Manufacturers	Final	Procedural, Manufacturing, GMP, Application Process
Hong Kong	DoH	Guidance on Application for Free Sale Certificate of Pharmaceutical Product and Certificate of Pharmaceutical Product	Final	Trade, Quality, Safety, Application Process, Procedural
Hong Kong	DoH	Phase Out of Manual Application Submission for Import and Export Licences/Certificates for Pharmaceutical Products and Dangerous Drugs	Final	Trade, Application Process, Procedural
Hong Kong	PBB Hong Kong	Guidance for Pharmaceutical Industry - Adverse Drug Reaction Reporting Requirements	Final	Safety, Pharmacovigilance
Hong Kong	PBB Hong Kong	Guidance on Application of Certificate for Clinical Trial - Advanced Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Clinical Trials
Hong Kong	PBB Hong Kong	Guidance on Application of Certificate of Drug/Product Registration — Advanced Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Application Process, Procedural
Hong Kong	PBB Hong Kong	Guidance on Record Keeping for Licensed Manufacturers and Licensed Wholesale Dealers – Advanced Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Procedural, Trade, Supply, Compliance
Hong Kong	PBB Hong Kong	Guidance on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Labeling, Safety
Hong Kong	PBB Hong Kong	Guidance on Classification of Advanced Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies, Product Classification
Hong Kong	PBB Hong Kong	Guidance Notes on the Application for Certificate for Clinical Trial/Medicinal Test	Final	Clinical Trials, Procedural
Hong Kong	PBB Hong Kong	Notice of requirement on reporting of local drug related safety report, progress report and final study report in clinical trial	Final	Clinical Trials, Safety, Pharmacovigilance
Hong Kong	PBB Hong Kong	How to Apply for Import and Export Licences for Pharmaceutical Products & Medicines (including products for clinical trial)	Final	Import, Trade, Procedural, Clinical Trials
Hong Kong	PBB Hong Kong	Guidance Notes on Registration of Pharmaceutical Products/Substances	Final	Application Process, Procedural
Hong Kong	PBB Hong Kong	Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity	Final	Application Process, Procedural, Biologics
Hong Kong	PBB Hong Kong	Guidance Notes on Registration of Biosimilar Products	Final	Application Process, Procedural, Biosimilars
Hong Kong	PBB Hong Kong	Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances	Final	Procedural, Variations
Hong Kong	PBB Hong Kong	Guidance Notes on Classification of Products as “Pharmaceutical Products” under the Pharmacy and Poisons Ordinance (Cap. 138)	Final	Product Classification
Hong Kong	PBB Hong Kong	Guidelines on the Labelling of Pharmaceutical Products	Final	Labeling
Hong Kong	PBB Hong Kong	General Requirements for Master Formula and Specifications for Non-Biological Products	Final	Quality, Safety, Efficacy
Hong Kong	PBB Hong Kong	Requirement of Elemental Impurities Levels/Limits in Registered Pharmaceutical Products	Final	Quality, Safety, Efficacy
Hong Kong	PBB Hong Kong	Requirement of Microbiological Quality of Registered Pharmaceutical Products in Non-sterile Dosage Forms	Final	Quality, Safety, Efficacy
Hong Kong	PBB Hong Kong	Supplementary Notes for Application for Registration of Biological Products Involving Alternative/Back Up Manufacturer(s) for Manufacturing Steps	Final	Application Process, Procedural, Manufacturing, GMP, Biologics, Vaccines
Hong Kong	PBB Hong Kong	Form/Template - Application for Registration as Authorized Person	Final	Procedural, Application Process, Compliance
Hong Kong	PBB Hong Kong	Form/Template - Application for Renewal of Registration as Authorized Person	Final	Procedural, Application Process, Compliance
Hong Kong	PBB Hong Kong	Guidance on Application for Registration as Authorized Person	Final	Procedural, Application Process, Compliance
Hong Kong	PBB Hong Kong	Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong (Version 4.3)	Final	Procedural, Compliance
India	CDSCO	Clarification if change in (a) Polymorphs/crystalline/amorphous/solvates/hydrate etc (b) salt and (c) Derivative/analogue/ester etc of already approved active substance to be considered as new drug if main active moiety (Active Pharmaceutical Ingredient-API) is same	Final	Application Process, Procedural
India	CDSCO	Notice - Module for online processing of applications for issuance of Written Confirmation Certificate	Final	Procedural, Application Process, Trade, Manufacturing, GMP, Quality
India	CDSCO	Notice - Evaluation of Certain pre-1988 permitted FDC de novo for manufacture of Sale in the Country without due approval from Central Licensing Authority	Final	Procedural, Administrative
Latvia	SAM	Baltic Regulatory Agencies e-PIL Project For Hospital Use Medicines	Final	Product Information, Labeling
Malaysia	NPRA	Drug Registration Guidance Document (DRGD), Third Edition, First Revision July 2021	Final	Application Process
Malaysia	NPRA	Guidance Note for Cell and Gene Therapy Products (CGTPs) Manufacturing Facility in Malaysia (1^st Edition)	Final	Cellular and Gene Therapy, Advanced Therapies, Manufacturing
Netherlands	CCMO	Site Suitability Declaration (VGO) as of 1 November 2021 obligatory for research with a medicinal product	Final	Clinical Trials, Procedural
Pakistan	DRAP	Circular: Compliance With Pharmacopeial Specification	Final	Quality, Safety, Manufacturing, Trade
Pakistan	DRAP	Revised Fee: Pharmaceutical Evaluation and Registration Division (PE&R) Division	Final	Procedural, Application Process
Philippines	FDA Philippines	Amendment to FDA Circular No. 2020-020, entitled, “Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug Manufacturers”	Final	Compliance, Inspection, Trade, Procedural
Philippines	FDA Philippines	Supplemental Guidelines to FDA Circular No. 2020-024 A, Entitled, “Amendment to FDA Circular No. 2020-024, Entitled Updated Guidelines for Application of Authorizations with the Food and Drug Administration in light of the Community Quarantine Declarations”	Final	Procedural, Administrative, Compliance
Philippines	FDA Philippines	Interim Guidelines on the Renewal of Current Good Manufacturing Practice (cGMP) Clearance of Foreign Drug Manufacturers	Final	GMP, Manufacturing, Quality, Trade
South Africa	SAHPRA	Pilot: BAU New Medicine Applications For Registration (Version 2)	Final	Application Process, Procedural
Switzerland	Swissmedic	Out-of-Stock – COVID-19 – Authorisations for the temporary import and distribution of human medicines – Update	Final	Trade, Supply, Distribution
Uganda	NDA	Conduct of Clinical Trials during the COVID-19 lockdown	Final	Clinical Trials
UK	HRA	Step by step guide to using IRAS for combined review	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, Supply
UK	MHRA	Clinical trials applications for Coronavirus (COVID-19)	Final	Clinical Trials
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
UK	MHRA	A Guide to Defective Medicinal Products	Final	Safety, Procedural, Pharmacovigilance
UK	MHRA	Medicines: get scientific advice from MHRA	Final	Application Process, Procedural, Product Development
UK	MHRA	Renewing Marketing Authorisations for medicines	Final	Application Process, Procedural
UK	MHRA	Acting as a Responsible Person (import)	Final	Procedural, Trade, Manufacturing, GMP, Supply
UK	MHRA	Importing investigational medicinal products into Great Britain from approved countries	Final	Clinical Trials, Quality, Manufacturing, GMP, Trade, Supply
UK	MHRA	Clinical trials for medicines: manage your authorisation, report safety issues	Final	Clinical Trials
US	FDA	Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis – Draft Guidance for Industry	Draft	Clinical, Antimicrobial
US	FDA	Field Alert Report Submission: Questions and Answers - Guidance for Industry	Final	Pharmaceutical Quality, CMC

Key:

WHO: World Health Organization

ICH: International Council for Harmonisation

PIC/S: Pharmaceutical Inspection Co-operation Scheme

TGA: Therapeutic Goods Administration

FAMHP: Federal Agency for Medicines and Health Products

HC: Health Canada

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

EMA: European Medicines Agency

Fimea: Finnish Medicines Agency

DoH: Department of Health

PBB Hong Kong: Pharmacy & Poisons Board of Hong Kong

CDSCO: Central Drugs Standard Control Organisation

SAM: State Agency of Medicines

NPRA: National Pharmaceutical Regulatory Agency

CCMO: Central Committee on Research Involving Human Subjects

DRAP: Drug Regulatory Authority of Pakistan

FDA Philippines: Food and Drug Administration Philippines

SAHPRA: South African Health Products Regulatory Authority

Swissmedic: Swiss Agency for Therapeutic Products

NDA: National Drug Authority

HRA: Health Research Authority

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration