Country	Organization	Document	Status	Category
International	WHO	Nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention of respiratory syncytial virus disease - Proposed addendum to Annex 2 of WHO Technical Report Series, No.1048	Draft	Clinical, Medical, Pharmacology
International	WHO	Technical Report Series (TRS 1052) - 57th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations	Final	Manufacturing, GMP, Quality, Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Sulfamethoxazole/Trimethoprim/Isoniazid/Pyridoxine	Final	Generics, Product Development, Bioequivalence
International	WHO	Recommended comparator products: Anti-tuberculosis Medicines	Final	Quality, Safety, Efficacy, Generics, Bioequivalence, Pharmacology
Australia	TGA	Consultation: Proposed amendments to the Poisons Standard – ACMS, ACCS & Joint ACMS-ACCS meetings, June 2024	Draft	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	Established acceptable intake for nitrosamines in medicines	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
Australia	TGA	Examples of boundary and combination products and their product category (Version 2.0)	Final	Product Classification, Combination Products
Canada	HC	Regulatory Requirements for Drug Identification Numbers	Final	Safety, Pharmacovigilance, Procedural
Canada	HC	Organization and document placement for Canadian module 1	Final	Procedural, Application Process
Denmark	DMA	Preparing, translating and distributing safety information (DHPC)	Final	Safety, Pharmacovigilance
Denmark	DMA	Declaration of the end of a Clinical Trial under the directive	Final	Clinical Trials
Denmark	DMA	Danish Drug Standards	Final	Quality, Safety, Efficacy
Denmark	DMA	Fees for clinical trials	Final	Clinical Trials
Egypt	EDA	Off-Site Nursing in Clinical Trials	Draft	Clinical Trials
Egypt	EDA	Guidelines On Naming of Human Pharmaceutical Products (Version 4)	Final	Procedural, Application Process
EU	HMA	Recommendations related to contraception and pregnancy testing in clinical trials (Version 1.2)	Final	Clinical Trials
EU	CMDh	Form/Template - Request for MRP/RUP/Update assessment report (CMDh/442/2022, Rev 3) [Track version]	Final	Application Process, Procedural
EU	EMA	Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence (EMA/CHMP/150527/2024)	Draft	Real World Data, Real World Evidence, Safety, Pharmacovigilance
EU	EMA	Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling	Draft	Safety, Pharmacovigilance, Labeling
EU	EMA	Concept paper on the revision of the Guideline on epidemiological data on blood transmissible infections	Draft	Blood Products
EU	EMA	Quick Guide: Transitional trials from EudraCT to CTIS (sponsor users) - CTIS Training Programme: Module 23 (Version 1.4)	Final	Clinical Trials, Procedural
EU	EMA	Template for scientific document (parts B-F) for an application for a paediatric investigation plan, including a deferral and a waiver	Final	Pediatrics, Clinical Trials, Procedural
EU	EMA	Scientific recommendations on classification of advanced therapy medicinal products (EMA/140033/2021)	Final	Cellular and Gene Therapy, Advanced Therapies, Product Classification, Application Process
EU	EMA	Acceptable intakes (AIs) established for N-nitrosamines - Appendix 1 to 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/154403/2024 /Rev. 4)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
EU	EMA	Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS (near infrared spectroscopy) Procedure (EMA/CHMP/CVMP/QWP/17760/2009 Rev 3)	Final	Quality
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev. 137)	Final	Safety, Pharmacovigilance
EU	EMA	EMA recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2024-2025	Final	Vaccines
EU	EMA	IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	ICH Q3C (R9) Guideline on impurities: guideline for residual solvents - Step 5 (EMA/CHMP/ICH/82260/2006)	Final	Quality, Safety, Manufacturing, GMP
EU	EMA	Guidance on good manufacturing practice and good distribution practice: Questions and answers	Final	Manufacturing, GMP, Quality
EU	EMA	Anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (body and Annexes 4 and 6) – General guidance (EMA/153000/2024 Rev. 2)	Final	Intellectual Property, Procedural, Safety, Pharmacovigilance
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/169204/2024)	Final	Product Information, Procedural
EU	EMA	Guide on access to unpublished documents (EMA/304162/2014 Rev.7)	Final	Administrative, Procedural
EU	EMA	Minimum inhibitory concentration (MIC) breakpoints (EMA/916812/2022)	Final	Antimicrobial
EU	EMA	MSSG recommendations to strengthen supply chains of critical medicinal products – Guidance document to facilitate the identification of regulatory measures to strengthen supply chains of critical medicinal products in the Union list (EMA/44164/2024)	Final	Supply
EU	EMA	Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products (EMA/670966/2020 Rev 6)	Final	Labeling, Packaging, Procedural
EU	EMA	Member states contact points for review of national versions of the content of mobile scanning and other technologies (EMA/358267/2015 Rev. 10)	Final	Procedural, Product Information
EU	EMA	Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group (EMA/934543/2022 Rev.3)	Final	Procedural, Product Information, Labeling
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 121)	Final	Safety, Pharmacovigilance
Finland	Fimea	Chargeable fees for trials under the EU Clinical Trials Regulation	Final	Clinical Trials
Hong Kong	DoH	Enhancement of Evaluation Procedures for Applications for Registration of Pharmaceutical Products under "1+" Mechanism	Final	Procedural, Application Process
Hong Kong	DoH	Guidance Notes on Classification of Products as “Pharmaceutical Products” under the Pharmacy and Poisons Ordinance (Cap. 138)	Final	Product Classification, Procedural, Application Process
Hong Kong	DoH	Guidance Notes on the Application for Certificate for Clinical Trial/Medicinal Test	Final	Clinical Trials
Hong Kong	DoH	Frequently Asked Questions on Application for the Certificate for Clinical Trial/Medicinal Test	Final	Clinical Trials
Hong Kong	DoH	Notice of requirement on reporting of local drug related safety report, progress report and final study report in clinical trial	Final	Safety, Pharmacovigilance, Clinical Trials
Hong Kong	DoH	Guidance Notes on New Account Registration for Electronic Clinical Trial System (e-CTS)	Final	Clinical Trials
Hong Kong	DoH	Frequently Asked Questions on Electronic Clinical Trial System (e-CTS)	Final	Clinical Trials
India	CDSCO	NOCs for manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose	Final	Trade, Procedural
Japan	PMDA	Revision of Notification on Handling of Submission of Electronic Study Data for New Drug Applications [Provisional Translation]	Final	Application Process, Electronic Submission
Japan	PMDA	Question and Answer Guide Regarding “Notification on Handling of Submission of Electronic Study Data for New Drug Applications [Provisional Translation]	Final	Application Process, Electronic Submission
Japan	PMDA	Revision of Technical Conformance Guide on Electronic Study Data Submissions [Provisional Translation]	Final	Application Process, Electronic Submission
Japan	PMDA	FAQs on Electronic Study Data Submission [Provisional Translation]	Final	Application Process, Electronic Submission
Japan	PMDA	Data Standards Catalog	Final	Procedural, Administrative, Application Process, Electronic Submission
Japan	PMDA	Study Data Validation Rules (Version 5.0)	Final	Procedural, Administrative, Application Process, Electronic Submission
Latvia	SAMLV	New online notification form for appointment of a contact person for pharmacovigilance issues at national level	Final	Safety, Pharmacovigilance
Lithuania	SMCA Lithuania	Regarding medicinal products for which “sunset clause” may already be applied	Final	Procedural, Administrative
Netherlands	CCMO	Template cover letter for Substantial Modification (SM)	Final	Clinical Trials
Netherlands	CCMO	Modification Description for Substantial Modification (SM)	Final	Clinical Trials
Pakistan	DRAP	Post-registration Variation Guidelines for Pharmaceutical and Biological Products (PE&R/GL/PV/001), 2nd Edition	Final	Variations, Biologicals
Philippines	FDA Philippines	Guidelines on the Classification of Deficiencies Observed During Inspection of the Conduct of Clinical Trials	Draft	Clinical Trials, Inspections, Compliance
Philippines	FDA Philippines	Guidelines on the Importation and Exportation Notification for Pharmaceutical Products and Raw Materials	Draft	Procedural, Trade, Supply
Saudi Arabia	SFDA	Registration According to Verification and Abridged (Version 2.2)	Final	Application Process
Saudi Arabia	SFDA	Breakthrough Medicine Program (Version 1.1)	Final	Application Process
South Africa	SAHPRA	Good Wholesaling Practice (GWP) Guideline for the Importers and Distributors of Scheduled Substances (SAHPGL-LIC-05_v1)	Final	Trade, Supply, Distribution
South Africa	SAHPRA	Guideline for Professional Information for Human Medicines (Categories A and D) (SAHPGL-CEM-02_v6)	Final	Product Information, Labeling
South Africa	SAHPRA	Payment of Retention Fees for the Year Ending 31 December 2024 in Respect of Medicines Registered Until 31 December 2023 and/or Various Licences	Final	Procedural, Application Process, Administrative
South Africa	SAHPRA	South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic	Final	Procedural, Clinical Trials, Compliance
South Africa	SAHPRA	EDQM CEP 2.0 Implementation	Final	Procedural, Quality, Manufacturing, GMP
Switzerland	Swissmedic	Guidance document - Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (Version 2.0)	Final	Trade, Supply, Procedural
Switzerland	Swissmedic	Guidance document - Authorisation of human medicinal product with known active substance (Version 5.1)	Final	Application Process
Switzerland	Swissmedic	Guidance document - Application establishment licence for medicinal products or TpP/GT/GMO (Version 6.0)	Final	Application Process, Manufacturing, GMP, Cellular and Gene Therapy, Advanced Therapies
Switzerland	Swissmedic	Form - Status of authorisation applications abroad (Version 3.0)	Final	Procedural, Application Process
Switzerland	Swissmedic	Guidance document - GMP compliance by foreign manufacturers (Version: 4.0)	Final	Manufacturing, GMP, Quality, Compliance
Switzerland	Swissmedic	Form - New authorisation of human medicinal products (Version 8.3)	Final	Application Process, Procedural
UK	HRA	Public involvement requirements for Confidentiality Advisory Group (CAG) applications	Final	Clinical Trials
UK	MHRA	Send and receive information on adverse drug reactions (ADRs)	Final	Safety, Pharmacovigilance
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
UK	MHRA	Medicines: apply for a variation to your marketing authorization	Final	Variations
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, risk assessment and confirmatory testing	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
UK	MHRA	Rolling review for marketing authorisation applications	Final	Procedural, Application Process
UK	MHRA	150-day assessment for national applications for medicines	Final	Procedural, Application Process
UK	MHRA	RegulatoryConnect	Final	Procedural, Application Process
US	FDA	Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs - Guidance for Industry	Draft	Labeling, Generics
US	FDA	Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers: Guidance for Industry	Draft	Labeling, Promotion, Advertising, Biosimilars
US	FDA	Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products – Draft Guidance for Industry	Draft	Cellular and Gene Therapy, Advanced Therapies, Tissue Products, Xenotransplantation
US	FDA	Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products - Draft Guidance for Industry	Draft	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Cancer Clinical Trial Eligibility Criteria: Laboratory Values - Draft Guidance for Industry, IRBs, and Clinical Investigators	Draft	Clinical Trials, Oncology
US	FDA	Cancer Clinical Trial Eligibility Criteria: Performance Status - Draft Guidance for Industry, IRBs, and Clinical Investigators	Draft	Clinical Trials, Oncology
US	FDA	Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications - Draft Guidance for Industry, IRBs, and Clinical Investigators	Draft	Clinical Trials, Oncology
US	FDA	Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels - Guidance for Industry	Final	Blood Products
US	FDA	Data Standards Catalog (Version 10.3)	Final	Administrative, Procedural
Zimbabwe	MCAZ	Prevention of Diethylene Glycol (DEG) and Ethylene Glycol (EG) Contamination in Pharmaceuticals	Final	Administrative, Procedural

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