Country	Organization	Document	Status	Category
International	ICH	E19: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials	Final	Clinical Trials, Safety
International	PIC/S	Revised Annex 1 (Manufacture of Sterile Medicinal Products) to Guide to Good Manufacturing Practice for medicinal products (PS/INF 26/2022 (Rev. 1))	Final	Manufacturing, GMP, Quality
Australia	TGA	Proposal for adoption of US FDA’s guideline on Submitting Documents Using RWD and RWE to FDA for drugs and biologics (FDA-2019-D-1263)	Draft	Real World Data, Real World Evidence
Australia	TGA	Proposal for adoption of US FDA’s guideline on Rare diseases: Natural history Studies for Drug Development (Draft) (FDA-2019-D-0481)	Draft	Orphans, Rare Diseases
Australia	TGA	Proposal for adoption of US FDA’s guideline on Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products (Draft) (FDA-2021-D-1214)	Draft	Real World Data, Real World Evidence
Australia	TGA	Proposal for adoption of US FDA’s guideline on Data Standards for Drug and Biological Product Submissions Containing Real-World Data (Draft) (FDA-2021-D-0548)	Draft	Real World Data, Real World Evidence
Australia	TGA	Proposal for adoption of US FDA’s guideline on Use of Electronic Health Records in Clinical Investigations (FDA-2016-D-1224)	Draft	Clinical Trials, Real World Data, Real World Evidence
Australia	TGA	Regulatory options to potentially allow references to the TGA in therapeutic goods advertising (Version 1.0)	Draft	Advertising, Promotion
Australia	TGA	Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings, November 2022	Draft	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	Product Information as a package insert in boxed injectables (Version 1.0)	Draft	Product Information, Packaging, Safety
Australia	TGA	Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017	Final	GMP, Manufacturing
Australia	TGA	Form - Notification of a new proprietary ingredient	Final	Procedural
Australia	TGA	Proposed amendments to the Poisons Standard in relation to paracetamol	Draft	Safety, Packaging, Dispensing
Canada	HC	Health Canada to monitor the inclusion of disaggregated data in clinical evidence: Notice to stakeholders	Final	Clinical Trials
Canada	HC	A guide to the new disaggregated data questionnaire for drug submissions	Final	Clinical Trials
Canada	HC	Guidance on nitrosamine impurities in medications	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality
Canada	HC	Guidance document: Preparation of regulatory activities in non-eCTD format	Final	Procedural, Application Process
Canada	HC	Regulatory enrolment process (REP)	Final	Procedural, Application Process
Denmark	DMA	Application for parallel import or parallel trade	Final	Procedural, Trade
Denmark	DMA	Questions and answers on the Clinical Trials Regulation	Final	Clinical Trials
Denmark	DMA	Deregistration of medicinal products	Final	Procedural, Administrative
Denmark	DMA	Fees payable for medicinal products and companies	Final	Procedural, Application Process
Denmark	DMA	Approval of packaging for dose dispensing of medicines	Final	Packaging, Dispensing
Denmark	DMA	Guideline on the "sunset clause" - notification about initiation or cessation of marketing of medicinal products	Final	Procedural, Administrative
Denmark	DMA	Guideline on Advertising, etc. of Medicinal Products for Human Use	Final	Promotion, Advertising
EU	EDQM	EDQM DCEP Sharing Tool - How to manage your account (PA/PH/CEP (21) 62, 1R)	Final	Procedural, Quality, Manufacturing, GMP
EU	EDQM	Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders	Final	Procedural, Quality, Manufacturing, GMP
EU	OCABR (EDQM)	Guideline for Pandemic COVID-19 Vaccine (mRNA)	Final	Vaccines, Quality, Safety, Efficacy
EU	EC	Clinical Trials Regulation (EU) No 536/2014: Questions & Answers (Version 6.2)	Final	Clinical Trials
EU	EC	EudraLex Volume 10 - Clinical trials guidelines: Part II application document templates - Investigator Curriculum Vitae (Version 3.6)	Final	Clinical Trials
EU	EC	EudraLex Volume 10 - Clinical trials guidelines: Part II application document templates - Declaration of Interest Template (Version 1.2)	Final	Clinical Trials
EU	EC	EudraLex Volume 10 - Clinical trials guidelines: Part II application document templates - Site Suitability Template (Version 1.2)	Final	Clinical Trials
EU	EC	EudraLex Volume 10 - Clinical trials guidelines: Part II application document templates - Statement of compliance with Regulation (EU) 2016/679 (GDPR)	Final	Clinical Trials
EU	EC	EudraLex Volume 10 - Clinical trials guidelines: Chapter III – Quality: Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries	Final	Clinical Trials, Manufacturing, GMP
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (CMDh/330/2015, Rev.35)	Final	Safety, Pharmacovigilance
EU	CMDh	Template for MAHs response during type II variations (CMDh/443/2022, Rev. 0)	Final	Procedural, Variations
EU	CMDh	Template for applicants to prepare report on similarity with authorised orphan medicinal products (CMDh/422/2020 Rev. 1)	Final	Procedural, Application Process, Rare Diseases, Orphans
EU	CMDh	Applicant's Response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (CMDh/091/2003, Rev.10) [Track version]	Final	Procedural, Application Process
EU	CMDh	RMS Validation Checklist for human medicinal products in DCP (CMDh/368/2017, Rev.7)	Final	Procedural, Application Process
EU	CMDh	Request for MRP/RUP/Update assessment report (CMDh/442/2022, Rev 1)	Final	Procedural, Application Process
EU	CMDh	CMDh Best Practise Guide on the compilation of the dossier for new applications submitted in Mutual Recognition & Decentralised procedures (CMDh/077/2008, Rev.5) [Track version]	Final	Procedural, Application Process
EU	CMDh	CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008	Final	Variations
EU	EMA	FAQs: How to evaluate a CTA - CTIS Training Programme: Module 06 (Version 1.4)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: How to create, submit and withdraw a CTA - CTIS Training Programme: Module 10 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	CTIS Evaluation Timelines - CTIS Training Programme (Version 1.0)	Final	Clinical Trials, Procedural
EU	EMA	Guide on CTIS Common features: Overview of CTIS workspaces and common system functionalities - CTIS Training Programme: Module 02 (Version 1.4)	Final	Clinical Trials, Procedural
EU	EMA	IRIS guide for Parallel Distribution applicants (EMA/805961/2018)	Final	Trade, Procedural, Application Process
EU	EMA	Explanatory note on pharmacovigilance fees payable to the European Medicines Agency	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Procedural advice for post-orphan medicinal product designation activities (EMA/469917/2018)	Final	Procedural, Orphans, Rare Disease
EU	EMA	IRIS guide for applicants (How to create and submit scientific applications, for industry and individual applicants) Version 2.12 (EMA/444925/2018)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	IRIS guide to registration and RPIs - Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration (Version 2.9)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	QRD product-information template (version 10.3) [Track version]	Final	Product Information, Procedural
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)	Final	Product Information, Labeling, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	ATMP product information template (Version 1)	Final	Product Information, Procedural, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	Appendix II to the QRD templates for human medicinal products - MedDRA terminology to be used in Section 4.8 “Undesirable effects” of SmPC (EMA/295934/2018), Version 5	Final	Product Information, Procedural, Safety, Pharmacovigilance
EU	EMA	QRD Appendix V - Adverse-drug-reaction reporting details (EMA/67830/2013, Version 25)	Final	Product Information, Procedural, Safety, Pharmacovigilance
EU	EMA	Checking process of mock-ups and specimens of outer/immediate labelling and package leaflets of human medicinal products in the centralised procedure (EMA/305821/2006/Rev.4)	Final	Packaging, Labeling, Procedural
EU	EMA	Specimen submission form	Final	Packaging, Labeling, Procedural
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 103)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources (EMA/787647/2022)	Draft	Real World Data, Real World Evidence
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/776517/2022)	Final	Product Information, Procedural
EU	EMA	Qualification opinion for Prognostic Covariate Adjustment (PROCOVA) as an Efficient Statistical Methodology, Intended to Improve the Efficiency of Phase 2 and 3 Clinical Trials by Using Trial Subjects’ Predicted Control Outcomes (Prognostic Scores) in Linear Covariate Adjustment (EMADOC-1700519818-907465)	Final	Clinical Trials
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.50)	Final	Procedural, Compliance, Administrative
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.118)	Final	Safety, Pharmacovigilance
EU	EMA	Concept Paper on the Establishment of a Guideline on the Development and Manufacture of Synthetic Peptides (EMA/CHMP/QWP/735422/2022)	Draft	Quality, Chemistry, Manufacturing and Controls, CMC
EU	EMA	Concept Paper on the Establishment of a Guideline on the Development and Manufacture of Synthetic Oligonucleotides (EMA/CHMP/QWP/735423/2022)	Draft	Quality, Chemistry, Manufacturing and Controls, CMC
EU	EMA	Questions and answers on labelling flexibilities for COVID-19 vaccines (EMA/726359/2022), Revision 4	Final	Labeling, Product Information, Vaccines
EU	EMA	All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) (EMA/CHMP/302620/2017 Rev. 2	Final	Labeling
EU	EMA	Consideration on core requirements for RMPs of COVID19 vaccines (EMA/PRAC/709308/2022), Version 3.1	Final	Safety, Pharmacovigilance, Vaccines
Finland	Fimea	Changes to the shortage notification fees payable by marketing authorisation holders and to the notification form as from 1 September 2022	Final	Procedural, Application Process
Finland	Fimea	The new decree on fees chargeable by the Finnish Medicines Agency entering into force on 1 September 2022	Final	Procedural, Application Process
Ireland	HPRA	Annual Review and Proposal for Fees - Financial Year 2023: Human Medicines, Compliance Activities, Blood, Tissue Establishments and Organs and Medical Devices	Draft	Procedural, Application Process
Japan	PMDA	Labeling of Codes on Containers to Identify Prescription Drugs	Final	Labeling, Safety
Nigeria	NAFDAC	Traceability of pharmaceutical products regulations	Draft	Labeling, Safety
Pakistan	DRAP	Virtual inspection of manufacturers abroad for registration of finished drugs and biologicals	Final	Inspections, Compliance, GMP, Manufacturing
Pakistan	DRAP	Guidelines on the management of high alert medication (PHSR/GL/HAM/010), 1st Edition	Final	Safety, Pharmacovigilance
Philippines	FDA Philippines	Amendment of FDA Circular No. 2021-025 Entitled “Guidelines for Application of Authorizations at the Food And Drug Administration in Light of the Extended State of Public Health Emergency”, Extending Further its Effectivity	Final	Procedural, Application Process, Compliance
Philippines	FDA Philippines	Amendment to Administrative Order No. 2020-0017 entitled, “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003”	Draft	Procedural, Application Process
Saudi Arabia	Saudi FDA	Guidance for Priority Review of Product Registration (Version 5.2)	Final	Application, Procedural
Saudi Arabia	Saudi FDA	Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products (Version 3.4)	Final	Manufacturing, GMP, Quality
Saudi Arabia	Saudi FDA	Guide to Good Manufacturing Practice for Medicinal Products (Version 4.1)	Final	Manufacturing, GMP, Quality
Saudi Arabia	Saudi FDA	The Policy of Appeal to Drug Sector Decisions (Version No. 1.2)	Final	Procedural, Administrative
Singapore	HSA	Guidance on the conduct of clinical trials in relation to the COVID-19 situation	Final	Clinical Trials
Singapore	HSA	Guidance on GCP compliance inspection framework (GN-IOCTB-11), Revision no 003	Final	Clinical Trials, Inspections, Compliance
South Africa	SAHPRA	Quality and bioequivalence guideline (SAHPGL-PEM-02), Version 8	Draft	Quality, Bioequivalence, Clinical Trials, Efficacy, Generics
South Africa	SAHPRA	BAU Variations Communication (SAHPGL-HPA-05), Version 4	Final	Variations
South Africa	SAHPRA	Variations addendum for human and veterinary medicines (SAHPGL-HPA-06), Version 6	Final	Variations
South Africa	SAHPRA	Guideline for Professional Information for Human Medicines (Categories A and D) (SAHPGL-CEM-02), Version 5	Final	Product Information
South Africa	SAHPRA	Guideline on the payment of fees to SAHPRA (Version 7)	Final	Application Process, Procedural
South Africa	SAHPRA	Electronic submission of clinical trial documents (amendments, bioequivalence studies, responses, notifications, and serious adverse events) (SAHPGL-CEM-CT-01), Version 3	Final	Clinical Trials, Application Process
South Africa	SAHPRA	Guideline for lot release of human vaccines (SAHPGL-PEM-BIO-01), Version 3	Final	Quality, Vaccines
South Africa	SAHPRA	Guideline for pre-registration consultation meeting (SAHPGL-PEM-BIO-03), Version 3	Final	Quality, Biologicals, Vaccines
South Africa	SAHPRA	Biological medicines amendment guideline (SAHPGL-PEM-BIO-05), Version 5	Final	Biologicals, Variations
South Africa	SAHPRA	Guideline on post importation testing (SAHPGL-INSP-01), Version 5	Final	Supply, Trade, Quality
South Africa	SAHPRA	Guideline on good manufacturing practice for medicines (SAHPGL-INSP-02), Version 8	Final	Manufacturing, GMP, Quality
South Africa	SAHPRA	Guideline on South African Good Wholesaling Practice for wholesalers (SAHPGL-INSP-03), Version 5	Final	Trade, Supply, Distribution
South Africa	SAHPRA	Guidelines for preparation of Site Master File (SAHPGL-INSP-04), Version 5	Final	Manufacturing, GMP, Safety, Application Process
South Africa	SAHPRA	Guideline on how to respond to a GMP, GWP, GCP or GVP inspection report (SAHPGL-INSP-05), Version 2	Final	Inspections, Compliance, Manufacturing, GMP, Clinical Trials, Safety, Pharmacovigilance, Supply
South Africa	SAHPRA	Guideline for fee determination and payments of GxP and product related inspections (SAHPGL-INSP-06), Version 2	Final	Inspections, Compliance, Manufacturing, GMP, Clinical Trials, Safety, Pharmacovigilance, Supply
South Africa	SAHPRA	Form - Licence Application to Manufacture Import or Export Medicines Scheduled Substances including Contract Testing Laboratories (GLF-LIC-01A), Revision 1	Final	Trade, Manufacturing, GMP, Procedural
South Africa	SAHPRA	Form - Licence Application to act as a Wholesaler of Medicines and Scheduled Substances (GLF-LIC-02A), Revision 1	Final	Trade, Supply, Distribution, Procedural
South Africa	SAHPRA	Form - Licence Application for a Wholesaler to Export Medicines (GLF-LIC-04A), Revision 1	Final	Trade, Supply, Distribution, Procedural
South Africa	SAHPRA	Form - Licence Application to Cultivate Manufacture or Import Cannabis for Medicinal Purposes (GLF-LIC-05A), Revision 1	Final	Procedural, Manufacturing, GMP
Switzerland	Swissmedic	Guidance document - Medicinal product name HMV4	Final	Procedural, Safety, Labeling
Switzerland	Swissmedic	Form – Drug Master File (DMF) HMV4	Final	Procedural, Quality, CMC, Chemistry, Manufacturing and Controls
Switzerland	Swissmedic	Form – New authorisation of human medicinal products HMV4	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document - Temporary authorisation for human medicinal products HMV4	Final	Application Process, Procedural
Switzerland	Swissmedic	Information sheet - Safety of Medicines	Final	Safety, Clinical Trials
Switzerland	Swissmedic	Information sheet - Mandatory notification regarding suspected illegal trading in medicinal products	Final	Procedural, Safety, Trade
Switzerland	Swissmedic	Guidance document - Authorisation in accordance with Art. 14 para.1 abis-quater TPA HMV4	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
Switzerland	Swissmedic	Potential nitrosamine contamination – harmonised implementation (update)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Procedural
Tanzania	TMDA	Submission of Appointment of Qualified Person for PharmacoVigilance (QPPV)	Final	Safety, Pharmacovigilance
Tanzania	TMDA	Guidelines for emergency use authorization of medicinal products (TMDA/DMC/MRE/G/018)	Final	Application Process, Safety
Tanzania	TMDA	Guidelines on Good Review Practices (TMDA/DMC/MRE/G/016)	Final	Application Process, Procedural, Administrative
UK	HRA	Proportionate Review toolkit	Final	Clinical Trials, Procedural
UK	HRA	Standard Operating Procedures for Research Ethics Committees (Version 7.6) [Summary of Changes]	Final	Clinical Trials, Procedural
UK	MHRA	European Commission Decision Reliance Procedure (EC DRP) extension	Final	Application Process
UK	MHRA	Good clinical practice for clinical trials	Final	Procedural, Clinical Trials
UK	MHRA	The Northern Ireland MHRA Authorised Route (NIMAR)	Final	Supply, Procedural
UK	MHRA	Project Orbis	Final	Application Process, Oncology, Procedural
UK	MHRA	MHRA phase I accreditation scheme	Final	Clinical Trials
UK	MHRA	MHRA fees	Final	Administrative, Procedural, Application Process
UK	MHRA	Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices	Final	GMP, Manufacturing, Inspections, Compliance
US	FDA	Facility Readiness: Goal Date Decisions Under GDUFA - Guidance for Industry	Draft	Generics
US	FDA	Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA - Guidance for Industry	Draft	Generics, Quality, Chemistry Manufacturing and Controls, CMC
US	FDA	Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules - Guidance for Industry	Final	Generics, Quality, Chemistry Manufacturing and Controls, CMC
US	FDA	Providing Over-the-Counter Monograph Submissions in Electronic Format - Guidance for Industry	Draft	Electronic Submissions, Application Process
US	FDA	Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency - Guidance for Industry	Final	Administrative, Procedural
US	FDA	How To Obtain a Covered Product Authorization - Guidance for Industry	Draft	Administrative, Procedural
US	FDA	Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products - Guidance for Industry	Draft	Labeling
US	FDA	Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products - Guidance for Industry	Draft	Labeling
US	FDA	Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products - Guidance for Industry	Final	Real World Data, Real World Evidence, Administrative, Procedural
US	FDA	Ethical Considerations for Clinical Investigations of Medical Products Involving Children - Guidance for Industry, Sponsors, and IRBs	Draft	Clinical Trials, Pediatrics
US	FDA	Q3D(R2) Elemental Impurities - Guidance for Industry	Final	Quality, Safety
US	FDA	General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products - Guidance for Industry	Draft	Clinical, Pharmacology, Pediatrics

Global Pharma Guidance Tracker – September 2022

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