Country	Organization	Document	Status	Category
International	PIC/S	PIC/S GMP Guide Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (PS/INF 25/2019 (Rev. 1))	Draft	Manufacturing
International	PIC/S	PIC/S GMP Guide Annex 2B: Manufacture of Biological Medicinal Substances and Products for Human Use (PS/INF 26/2019 (Rev. 1))	Draft	Manufacturing
International	ICH	Cover statement on the 2019 Error Correction to Revise Ethylene Glycol Q3C PDE	Final	Quality
Australia	TGA	Guidelines for making an offer of enforceable undertaking to the TGA	Final	Compliance
Australia	TGA	Improved Consumer Medicine Information template	Final	Product Information
Australia	TGA	Consumer Medicine Information (CMI): How to use the improved CMI template	Final	Product Information
Australia	TGA	Labelling changes: information for health professionals	Final	Product Information, Labeling
Australia	TGA	Labelling changes: information for sponsors	Final	Product Information, Labeling
Australia	TGA	High-moderate risk changes to permissible ingredients – Caffeine	Final	Safety
Belgium	FAMHP	Information on the Falsified Medicines Directive available in the online medicines database	Final	Safety, Labeling
Belgium	FAMHP	Falsified Medicines Directive: End of transition period and beginning of monitoring activities	Final	Safety, Labeling
Canada	HC	Mandatory use of the Electronic Common Technical Document (eCTD) format	Final	Procedural, Application Process
Denmark	DMA	Guideline for applications for authorisation of clinical trials of medicinal products in humans	Final	Clinical Trials
Denmark	DMA	Variations after 1 January 2010 - Questions and Answers	Final	Variations
Denmark	DMA	Summaries of product characteristics, package leaflets and labelling	Final	Product Information, labeling
Denmark	DMA	Form for cataloguing active substances of proprietary medicinal products etc	Final	Clinical Trials, Procedural
Denmark	DMA	Application for parallel import	Final	Trade
Denmark	DMA	Companies' reporting obligation and duty to inform about relationships with healthcare professionals	Final	Ethics
Denmark	DMA	Declaration of the end of a Clinical Trial	Final	Clinical Trials
EU	EC	Safety features for medicinal products for human use: Questions and Answers (version 16)	Final	Safety, Labeling
EU	EDQM	Guide to the quality and safety of tissues and cells for human application	Final	Safety, Quality
EU	CMDh	Overview of timetables 2020: CMDh 60-day procedures for MRP/DCP applications (CMDh/183/2010, Rev.9)	Final	Procedural, Application Process
EU	CMDh	Timetable 2020 for requests to CMDh for a recommendation on classification of an unforeseen variation - Article 5 of Commission Regulation (EC) No. 1234/2008, as amended (CMDh/182/2010, Rev.10)	Final	Variations
EU	CMDh	CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008	Final	Variations
EU	CMDh	Monitoring of medicines originating from Japan (CMDh/241/2011, Rev.8)	Final	Safety
EU	CMDh	Cover letter template for renewals (CMDh/364/2017, Rev.4)	Final	Procedural
EU	CMDh	Template - RMS End of Renewal Procedure (CMDh/219/2008/Rev.5)	Final	Procedural
EU	CMDh	Information on nitrosamines for marketing authorisation holders: Request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients (CMDh/404/2019)	Final	Quality, Safety, Efficacy
EU	CMDh	Questions and answers on “Information on nitrosamines for marketing authorisation holders” (CMDh/405/2019)	Final	Quality, Safety, Efficacy
EU	CMDh	Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008 (CMDh/CMDv/132/2009, Rev.54) [Track version]	Final	Variations
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product	Final	Pharmacovigilance, Safety
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.1) [Track version]	Final	Quality, Safety, Efficacy, Variations
EU	EMA	New Organization First User QPPV/RP or Change of EU QPPV/RP (EMA/503895/2018)	Final	Pharmacovigilance, Safety
EU	EMA	Template/Form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance and trusted deputy (EMA/204890/2017)	Final	Pharmacovigilance, Safety, Procedural
EU	EMA	Dates of 2020 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/444946/2017)	Final	Procedural, Application Process
EU	EMA	EMA EudraVigilance Registration Manual (EMA/381729/2019, Rev. 2)	Final	Pharmacovigilance, Safety
EU	EMA	QRD product-information template (version 10.1) [Track version]	Final	Product Information, Procedural
EU	EMA	Qualification opinion on eSource Direct Data Capture (DDC) (EMA/CHMP/SAWP/483349/2019)	Final	Clinical Trials
EU	EMA	Important medical event terms list version (MedDRA version 22.1) (EMA/175234/2019)	Final	Pharmacovigilance, Safety
EU	EMA	Inclusion/exclusion criteria for the “Important Medical Events” list (EMA/494099/2019)	Final	Pharmacovigilance, Safety
EU	EMA	Explanatory note - Letter of representation for referral procedure under Article 31 of Directive 2001/83/EC	Final	Pharmacovigilance, Safety
EU	EMA	Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a development medicinal product (EMA/525101/2014)	Final	Pharmacovigilance, Safety
EU	EMA	eXtended EudraVigilance medicinal product dictionary (XEVMPD) data-entry tool user manual (Version 5.5)	Final	Pharmacovigilance, Safety
EU	EMA	Preparedness of medicines’ clinical trials in paediatrics: Recommendations by the Enpr-EMA working group on trial preparedness	Draft	Pediatrics, Clinical Trials
EU	EMA	Paediatric investigation plans: questions and answers	Final	Pediatrics, Clinical Trials
Finland	Fimea	The process for notifying shortages will change gradually starting from 1 October 2019	Final	Supply
Ireland	HPRA	EU Falsified Medicines Legislation – Update on National Arrangements for Implementation	Final	Safety, Labeling
Singapore	HSA	Online Application for Consignment Approval of Unregistered Therapeutic Products for Patients’ Use	Final	Procedural, Compassionate Use
Singapore	HSA	FAQs on the Online Application for Consignment Approval of Unregistered Therapeutic Products for Patients’ Use	Final	Procedural, Compassionate Use
Slovakia	SIDC	Submission of the marketing authorisation application via DCP, MRP	Final	Procedural, Application Process
Slovakia	SIDC	Submission of the marketing authorisation application via national procedure	Final	Procedural, Application Process
South Africa	SAHPRA	Requirements for non-resubmission of new registration backlog applications	Final	Procedural
South Africa	SAHPRA	Liability insurance for clinical trials	Draft	Clinical Trials
South Africa	SAHPRA	Guideline for handling Dear Healthcare Professional Letters relating medicine safety	Draft	Safety, Pharmacovigilance
Switzerland	Swissmedic	Fixed texts for medicinal products which are being reallocated from dispensing category C to B as of 2019	Final	Product Classification
Switzerland	Swissmedic	Form: New authorisation for co-marketing of medicinal product HMV4	Final	Procedural, Application Process
Switzerland	Swissmedic	Fast-track authorisation procedure HMV4	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document: Temporary authorisation for human medicinal products HMV4	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document: Packaging for human medicinal products HMV4	Final	Procedural
Switzerland	Swissmedic	Form: Renewal of authorisation HMV4	Final	Procedural
UK	MHRA	Parallel export and hoarding of restricted medicines	Final	Trade, Supply
UK	MHRA	Medicines that cannot be parallel exported from the UK	Final	Trade, Supply
UK	MHRA	Variations to Marketing Authorisations (MAs) after Brexit	Final	Procedural, Variations
UK	MHRA	Medicines: reclassify your product	Final	Product Classification
UK	MHRA	Good clinical practice for clinical trials	Final	Clinical Trials
UK	MHRA	Exporting active substance manufactured in the UK in a no-deal Brexit	Final	Procedural, Trade
UK	MHRA	Applying for a Certificate of Pharmaceutical Product after Brexit	Final	Procedural, Trade
UK	MHRA	Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letters to industry	Final	Procedural
UK	MHRA	MHRA guidance and publications about a possible no-deal Brexit	Final	Procedural
UK	MHRA	Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit	Final	Pharmacovigilance, Safety
UK	MHRA	How to draft a direct healthcare professional communication	Final	Safety
UK	MHRA	Good laboratory practice (GLP) for safety tests on chemicals	Final	Safety
UK	MHRA	Register to make submissions to the MHRA if there is a no-deal Brexit	Final	Procedural, Application Process
UK	MHRA	Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit	Final	Procedural
US	FDA	Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders	Draft	Procedural
US	FDA	Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy: Guidance for Industry	Final	Procedural
US	FDA	Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment - Guidance for Industry	Final	Clinical, Medical
US	FDA	Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older - Guidance for Industry	Final	Clinical, Medical, Clinical Pharmacology
US	FDA	Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers	Final	Biopharmaceutical
US	FDA	Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry	Final	Blood Products
US	FDA	Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products	Draft	Clinical, Medical, Clinical Trials

Global Pharma Guidance Tracker – September 2019

More from Global Pharma Guidance Update

More from Regulatory Trackers