Country	Organization	Document	Status	Category
International	WHO	Revision of WHO GMP for sterile pharmaceutical products – A joint EU, PIC/S, WHO project (QAS/17.745/Rev.1)	Draft	Manufacturing, GMP Quality, Safety, Efficacy
International	WHO	WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human insulin	Final	Application Process, Procedural, Biologics
International	WHO	WHO Guidelines on submission of documentation for the pilot procedure for prequalification of biotherapeutic products for human insulin – Full assessment pathway: Preparation of product dossiers in common technical document format	Final	Application Process, Procedural, Biologics
International	WHO	WHO Guidelines on submission of documentation for the pilot procedure for prequalification of human insulin approved by stringent regulatory authorities – Abridged assessment pathway	Final	Application Process, Procedural, Biologics
International	WHO	Quality Overall Summary: Product Dossier (QOS-BTP) – Template under WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human insulin	Final	Application Process, Procedural, Biologics
International	WHO	Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Authority (SRA) (QIS-BTP-SRA) – Template under WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human insulin	Final	Application Process, Procedural, Biologics
International	WHO	Guidelines for the safe production and quality control of poliomyelitis vaccine: Amendments (2020) to Annex 4 of WHO Technical Report Series, No. 1016	Draft	Vaccines
International	ICH	Detection of reproductive and developmental toxicity for human pharmaceuticals S5(R3)	Final	Safety, Toxicology
Australia	TGA	Brexit - Implications for therapeutic goods in Australia	Final	Procedural
Australia	TGA	Guidance for TGO 101: Standard for tablets, capsules and pills	Final	Quality, Safety, Efficacy
Australia	TGA	Microbiological quality of medicinal cannabis products: Complying with Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018	Final	Quality, Safety, Efficacy
Belgium	FAMHP	Unavailable medicines: New legislative measures	Final	Supply
Canada	HC	Draft Guidance Document: Comparative Pharmacokinetic Studies for Orally Inhaled Products	Draft	Safety, Efficacy, Clinical Trials
Canada	HC	Implementation of eCTD for clinical trial regulatory activities	Final	Clinical Trials, Application Process, Regulatory
Denmark	DMA	Clinical trials - Questions and answers	Final	Clinical Trials
EU	EDQM	Recommendations to stakeholders on plasma supply management	Final	Blood Products
EU	CMDh	CMDh Best Practice Guide on Multilingual Packaging (CMDh/413/2019, Rev.1)	Final	Labeling, Packaging
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (CMDh/330/2015, Rev.23, February 2020)	Final	Pharmacovigilance, Safety
EU	CMDh	Chapter 1 - CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing (CMDh/291/2013, Rev.20) [Track version]	Final	Variations, Procedural
EU	CMDh	“Blue – Box” requirements (CMDh/258/2012/Rev.20) [Track version]	Final	Labeling, Product Information
EU	CMDh	CMDh annotated QRD template for MR/DC procedures (CMDh/201/2005, Rev.10) [Track version]	Final	Packaging, Labeling, Product Information
EU	EMA	Qualification opinion on Multiple sclerosis clinical outcome assessment (MSCOA) (EMA/CHMP/SAWP/74371/2020)	Final	Clinical, Medical
EU	EMA	Emerging safety issues (ESI) contact points at the national competent authority (NCA) level (EMA/425422/2017 Corr. 1)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Template: Standalone signal notification form (EMA/150823/2017 Corr. 1)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	National contact points for standalone signal notifications (EMA/777916/2017 Corr. 1)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 75)	Final	Inspection, Pharmacovigilance
EU	EMA	Template: Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)	Final	Procedural
EU	EMA	ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals - Step 5 (EMA/CHMP/ICH/544278/1998)	Final	Safety, Toxicology
EU	EMA	ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials - Step 5 (EMA/CHMP/ICH/436221/2017)	Final	Clinical Trials
EU	EMA	Checklist for sponsors applying for the transfer of orphan medicinal product designation (EMA/41277/2007 Rev. 11)	Final	Procedural, Orphans, Rare Diseases, Application Process
EU	EMA	Template: Mutual-recognition, decentralised and referral product-information template (Version 4.1)	Final	Procedural, Labeling, Product Information
EU	EMA	Template: Connecting to the Agency ESTRI Gateway using an AS2 compatible product	Final	Procedural
EU	EMA	Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Introduction – EU Implementation Guide (EMA/676106/2019)	Final	Application Process, Procedural, Product Information
EU	EMA	Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Chapter 1: Registration requirements (EMA/676105/2019)	Final	Application Process, Procedural, Product Information
EU	EMA	Product Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Chapter 2: Initial submission of medicinal products (EMA/676107/2019)	Final	Application Process, Procedural, Product Information
EU	EMA	Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Chapter 6: Technical specifications	Final	Application Process, Procedural, Product Information
EU	EMA	Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Chapter 7: XEVMPD - PMS Migration guide	Final	Application Process, Procedural, Product Information
EU	EMA	Substances, Products, Organisations, Referentials (SPOR) SPOR API v2 Specification (EMA/676296/2019)	Final	Application Process, Procedural, Product Information
EU	EMA	ICH M9 guideline on biopharmaceutics classification system-based biowaivers Step 5 (EMA/CHMP/ICH/493213/2018)	Final	Quality, Safety, Efficacy, Generics
EU	EMA	ICH M9 guideline on biopharmaceutics classification system-based biowaivers - Questions and answers: Step 5 (EMA/CHMP/ICH/10044/2020)	Final	Quality, Safety, Efficacy, Generics
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.19)	Final	Procedural, Compliance
EU	EMA	Template: Dossier administrative validation checklist	Final	Procedural, Application Process
EU	EMA	Member states contact points for translations review (EMA/102302/2005 v. 6.15)	Final	Procedural
EU	EMA	Template: Day 80 assessment report - Clinical template with guidance (Rev.02.20)	Final	Procedural
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	Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group (EMA/828662/2017 rev.4)	Final	Labeling, Product Information
EU	EMA	Template - Orphan designation sponsor’s name and/or address change notification letter	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Quality of medicines - Questions and Answers: Part 1	Final	Quality, Safety
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (EMA/630645/2012 Rev.88)	Final	Pharmacovigilance, Safety
EU	EMA	Pharmacovigilance Fees: Questions and Answers	Final	Pharmacovigilance, Safety
Finland	FIMEA	FIMEA has switched to electronic signatures for marketing authorisation decisions	Final	Application Process, Procedural
India	CDSCO	Submission and processing of application for Registration Certificate and import License in parallel with New Drug application	Final	Application Process, Procedural, Trade
India	CDSCO	Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export	Final	Clinical Trials, Application Process, Procedural
India	CDSCO	Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/Bioequivalence (BA/BE) Studies, Grant of COPP	Final	Clinical Trials, Application Process, Procedural, Trade
India	CDSCO	Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019	Final	Clinical Trials, Application Process, Procedural
India	CDSCO	Notice regarding FAQs on New Drugs & Clinical Trial Rules 2019	Final	Clinical Trials
India	NPPA	Submission of data with respect to select APIs by merchant importers/stockists/manufacturers of APIs/formulations in the country: List of 58 APIs and format for submitting data	Final	Supply, Trade
Ireland	HPRA	Brexit Transitional Period: Implications for Medicine and Medical Device Companies up to 31 December 2020	Final	Procedural
Latvia	SAM	New price list of the paid services of the State Agency of Medicines from 1 January 2020	Final	Procedural, Application Process
Lithuania	SMCA	Regarding medicinal products for which “sunset clause” may already be applied	Final	Procedural
Pakistan	DRAP	Establishing regulatory pathway for establishment licensing system: A progressive approach	Draft	Manufacturing, Application Process, Procedural
Philippines	FDA Philippines	Guidelines for Pharmaceutical Industry on Pharmacovigilance	Final	Pharmacovigilance, Safety
Philippines	FDA Philippines	Guidelines On The Registration Of Human Influenza Vaccines	Final	Vaccines, Application Process
Saudi Arabia	SFDA	Guidance for Naming of Medicinal Products (Version 1.0)	Final	Procedural, Safety, Labeling
Saudi Arabia	SFDA	Guidance for Graphic Design of Medication Packaging	Final	Packaging, Labeling
Saudi Arabia	SFDA	Guideline on Plasma Donation for Plasma Derived Medicinal Products	Draft	Product Development
South Africa	SAHPRA	Clinical laboratory competence for clinical trials in South Africa	Draft	Clinical Trials
UK	MHRA	Medicines: Apply for a parallel import licence	Final	Procedural, Trade
UK	MHRA	Advertise your medicines	Final	Advertising, Promotion
UK	MHRA	Medicines that cannot be parallel exported from the UK	Final	Trade, Supply, Procedural
UK	MHRA	Apply for a licence to market a medicine in the UK	Final	Procedural, Application Process
UK	MHRA	Medicines: Marketing authorisation holders submission of Nitrosamine risk evaluation	Final	Pharmacovigilance, Safety
US	FDA	Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry	Final	Electronic Submissions
US	FDA	Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics: Guidance for Industry	Draft	Pharmacology, Toxicology
US	FDA	Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed: Guidance for Industry	Draft	Biosimilarity
US	FDA	Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment - Guidance for Industry	Draft	Clinical, Medical
US	FDA	Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments: Technical Specifications Document	Final	Safety, Pharmacovigilance
US	FDA	Withdrawn CDER Product Specific Guidances	Final	Generic Drugs, Procedural
US	FDA	Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II): Guidance for Industry	Final	Blood Products
US	FDA	Chapter 53 - 7353.001c Risk Evaluation and Mitigation Strategies	Final	Safety

Global Pharma Guidance Tracker – February 2020

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