Country	Organization	Document	Status	Category
International	WHO	WHO Preferred Product Characteristics for Next-Generation Influenza Vaccines	Draft	Clinical, Medical, Vaccines
International	WHO	Recommendations to assure the quality, safety and efficacy of rotavirus vaccines - Proposed revision of Annex 3 of WHO Technical Report Series, No. 941 (WHO/BS/2024.2474: Draft version)	Draft	Clinical, Medical, Vaccines
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 (WHO/BS/2024.2475: Draft version)	Draft	Clinical, Medical, Pharmacology
International	WHO	Recommended comparator products: Medicines for HIV/AIDS and related diseases	Final	Quality, Safety, Efficacy, Generics, Bioequivalence, Pharmacology
International	WHO	Recommended comparator products: Neglected Tropical Diseases	Final	Quality, Safety, Efficacy, Generics, Bioequivalence, Pharmacology
International	WHO	Notes on the Design of Bioequivalence Study: Arpraziquantel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Artemether/Lumefantrine	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the design of bioequivalence study: Isoniazid/Rifapentine	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the design of bioequivalence study: Isoniazid/Rifapentine/Moxifloxacin	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the design of bioequivalence study: Isoniazid/Rifapentine/Moxifloxacin/Pyrazinamide	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Lamivudine/Zidovudine	Final	Generics, Product Development, Bioequivalence
Australia	TGA	Updates to medicine labelling rules - Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety (Version 1.1)	Draft	Labeling, Packaging
Australia	TGA	Reforming Australia’s Therapeutic Goods Testing Regulations (Version 1.0)	Draft	Trade, Compliance, Quality, Safety, Efficacy
Australia	TGA	Boundary and combination products - Consultation on legislating regulatory categories (Version 1.0)	Draft	Product Classification
Australia	TGA	GMP requirements for medicinal products - PIC/S Guide to GMP PE009-16 (Version 1.0)	Final	Manufacturing, GMP, Inspections, Compliance
Australia	TGA	Authorised Prescriber - Special Access Scheme & Authorised Prescriber Scheme Online System guidance (Version 1.8)	Final	Compassionate Use, Procedural
Australia	TGA	Form - Request for certificate, or certified copy of TGA licences and certificates (Part A) or copy of Conformity Assessment Certificates (Part B)	Final	Procedural, GMP, Manufacturing, Trade
Australia	TGA	Form - Six monthly report - supply of unapproved therapeutic goods by a sponsor	Final	Compassionate Use, Supply, Procedural
Australia	TGA	Six monthly report - supply of unapproved therapeutic goods A step-by-step guide to completing the form (Version 2.0)	Final	Compassionate Use, Supply, Procedural
Australia	TGA	Form - Influenza reagents order form	Final	Procedural, Administrative, Vaccines
Australia	TGA	Assessed listed medicines evidence guidelines (Version 1.3)	Final	Application Process
Australia	TGA	Cosmetics or therapeutic goods: Guidance for advertisers and suppliers (Version 1.0)	Final	Product Classification, Advertising, Promotion
Australia	TGA	Good Clinical Practice (GCP) Inspection Program - Guidance for GCP inspection of clinical trial sites for investigational biologicals, medicines and medical devices	Final	Clinical Trials, Inspections, Compliance
Canada	HC	Consultation: Notice of intent to amend the regulations to address health product shortages in Canada	Draft	Supply, Distribution, Compliance
Canada	HC	Updated: Master File Application Form (Version 1.1.0)	Final	Quality, GMP, Manufacturing
Croatia	HALMED	Obligation to submit a variation application following PSUSA procedure	Final	Variations, Product Information
Denmark	DMA	Safety reporting during clinical medicinal trials	Final	Clinical Trials, Safety, Pharmacovigilance
Denmark	DMA	Flow chart - Guidance on risk-based recording and reporting of adverse reactions under CTR (Version1.0)	Final	Clinical Trials, Safety, Pharmacovigilance
Denmark	DMA	Submission of annual safety reports for clinical trials	Final	Clinical Trials, Safety, Pharmacovigilance
Denmark	DMA	Reporting of suspected serious unexpected adverse reactions to the EudraVigilance database for clinical trials with medicinal products	Final	Clinical Trials, Safety, Pharmacovigilance
Denmark	DMA	Registration of new investigational medicinal products in the EudraVigilance database (XEVMPD)	Final	Clinical Trials, Procedural, Safety, Pharmacovigilance
Denmark	DMA	Stocks of critical medicines	Final	Supply, Distribution, Compliance
Denmark	DMA	Danish Drug Standards	Final	Quality, Safety, Efficacy
Denmark	DMA	GMP and Quality of IMP	Final	Manufacturing, GMP, Quality, Clinical Trials
Denmark	DMA	Substantial modifications	Final	Clinical Trials, Procedural
Denmark	DMA	Transition of clinical trials from Directive to Regulation	Final	Clinical Trials, Procedural
Denmark	DMA	End of trials with medicinal products and reporting of results	Final	Clinical Trials, Procedural, Compliance
Denmark	DMA	The Danish GCP Units guide to transition of trials from EudraCT to CTIS (Version 1.4)	Final	Clinical Trials, Procedural
Ethiopia	EFDA	Guideline for Registration of Medicine (Version 005), Revised version posted online June 2024	Final	Application Process
Ethiopia	EFDA	Guideline for WHO Collaborative registration procedure (Version 002), Revised version posted online June 2024	Final	Application Process
Ethiopia	EFDA	Guideline for Non-Routine Registration (Version 001), Revised version posted online June 2024	Final	Application Process
Ethiopia	EFDA	Guideline Variation Application to Registered Medicines (Version 002), Revised version posted online June 2024	Final	Variations
Ethiopia	EFDA	Guideline on Medical Products Special import permit (Version 002), Revised version posted online June 2024	Final	Trade, Supply, Compassionate Use
Ethiopia	EFDA	Guidelines on Reliance for Regulatory Decision Making for Marketing Authorization (Version 002), Revised version posted online June 2024	Final	Application Process, Policy
Ethiopia	EFDA	Guideline for Registration of Radiopharmaceuticals(Version 001), Revised version posted online June 2024	Final	Application Process
Ethiopia	EFDA	Guideline for Medical gas Evaluation and Marketing Authorization (Version 001), Revised version posted online June 2024	Final	Application Process, Quality
Ethiopia	EFDA	Guideline for regulation of advertisement and promotion of medicines (Version 002), Revised version posted online June 2024	Final	Advertising, Promotion
Ethiopia	EFDA	Guideline for Medicine Product information (Version 002), Revised version posted online June 2024	Final	Product Information
Ethiopia	EFDA	Guideline for Preparation and Publication of Public Assessment Reports (Version 002), Revised version posted online June 2024	Final	Procedural
Ethiopia	EFDA	Guideline for Renewal of Marketing Authorization (Version 002), Revised version posted online June 2024	Final	Application Process
Ethiopia	EFDA	Guideline on Variation Applications to Registered Vaccines (Version 002), Revised version posted online June 2024	Final	Variations, Vaccines
Ethiopia	EFDA	Guideline for Registration of Antiseptics and Disinfectants (Version 002), Revised version posted online June 2024	Final	Application Process, Clinical, Medical
Ethiopia	EFDA	Guideline for conditional approval of Medicines (Version 002), Revised version posted online June 2024	Final	Application Process
Ethiopia	EFDA	Guideline for Good Review Practices (GRevPs) (Version 002), Revised version posted online June 2024	Final	Procedural, Policy
Ethiopia	EFDA	Guideline for Waiver of In vivo Bioequivalence study (Version 003), Revised version posted online June 2024	Final	Quality, Safety, Efficacy, Generics, Bioequivalence
Ethiopia	EFDA	Guideline for Registration of Oral Care and Skin Care Products with Therapeutic Claims (Version 002), Revised version posted online June 2024	Final	Application Process, Clinical, Medical
Ethiopia	EFDA	Guideline for Registration of Biotherapeutic Protein Products Prepared by Recombinant DNA Technology (Version 002), Revised version posted online June 2024	Final	Application Process, Biologicals
Ethiopia	EFDA	Guideline for describing the role and responsibly of Market Authorization Lead executive Office (Version 001), Revised version posted online June 2024	Final	Application Process, Procedural, Administrative
Ethiopia	EFDA	Guideline for Registration of Vaccine (Version 002), Revised version posted online June 2024	Final	Application Process, Vaccines
Ethiopia	EFDA	Guidelines for Registration of Similar Biotherapeutic Products (SBPs) (Version 002), Revised version posted online June 2024	Final	Application Process, Biosimilars
EU	EDQM	Implementation of the European Pharmacopoeia Supplement 11.6 – Notification for CEP holders	Final	Procedural, Quality, Manufacturing, GMP
EU	EC	European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation [Track version]	Draft	Variations
EU	EC	Executive summary for proposed amendments to the European Commission guidelines on variations categories and procedures (EMA/269251/2024)	Final	Variations
EU	HMA	CTCG Best Practice Guide for sponsors of multinational clinical trials with different Part I document versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 (Version 5)	Final	Clinical Trials, Procedural
EU	HMA	Cover letter template - Annex I to the CTCG Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 (Version 5)	Final	Clinical Trials, Procedural
EU	HMA	Fees for transition trials in Member States in EU/EEA (Annex II to the CTCG Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014)), Version 1	Final	Clinical Trials, Procedural
EU	HMA	CTCG’s Question and Answers on safety related issues in amendment of the Commission’s QnA section 7 on safety, Eudralex Vol 10	Final	Clinical Trials, Procedural, Safety
EU	CMDh	Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (CMDh/132/2009, Rev.62) [Track version]	Final	Variations
EU	CMDh	Mock-ups, specimens and samples – Variation (CMDh/261/2012, Rev.5) [Track version]	Final	Variations
EU	EMA	Concept paper on the revision of the COVID-19 vaccines guidance documents (EMA/CHMP/276798/2024)	Draft	Clinical, Medical, Vaccines
EU	EMA	Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis (EMA/CHMP/96250/2024)	Draft	Clinical, Medical
EU	EMA	Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance (EMA/CHMP/518671/2023)	Draft	Generics, Product Development, Bioequivalence
EU	EMA	Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance (EMA/94136/2024)	Draft	Generics, Product Development, Bioequivalence
EU	EMA	Budesonide, prolonged release tablets, 9 mg product-specific bioequivalence guidance (EMA/CHMP/219378/2024)	Draft	Generics, Product Development, Bioequivalence
EU	EMA	Budesonide, gastro-resistant hard capsules, 3 mg, gastro-resistant granules, 9 mg product-specific bioequivalence guidance (EMA/CHMP/219288/2024)	Draft	Generics, Product Development, Bioequivalence
EU	EMA	Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance (EMA/CHMP/219393/2024)	Draft	Generics, Product Development, Bioequivalence
EU	EMA	Guidance for applicants: pre-CTA advice pilot - ACT EU priority action on consolidated advice (EMA/253080/2024)	Final	Clinical Trials
EU	EMA	Guidance for applicants: SAWP CTCG pilot on scientific advice (EMA/256809/2024)	Final	Clinical Trials
EU	EMA	Clinical Trials Information System (CTIS) - Sponsor Handbook (EMA/923413/2022 – v. 4.0)	Final	Clinical Trials, Procedural
EU	EMA	CTIS Structured data form - Notifications and Results: Sponsor support material (EMA/297654/2021)	Final	Clinical Trials, Procedural
EU	EMA	CTIS Structured data form Instructions - Request for Information (RFI): Sponsor support material (EMA/599358/2021)	Final	Clinical Trials, Procedural
EU	EMA	CTIS Structured data form Instructions - initial application, additional MSC, substantial and non-substantial modifications: Sponsor support material (EMA/343883/2021)	Final	Clinical Trials, Procedural
EU	EMA	CTIS Structured data form Instructions - multi trial substantial modification: Sponsor support material (EMA/380784/2021)	Final	Clinical Trials, Procedural
EU	EMA	Revised CTIS transparency rules and historical trials: quick guide for users (Version 1.6)	Final	Clinical Trials, Compliance
EU	EMA	Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) (EMA/212507/2021) (Version 2)	Final	Clinical Trials, Compliance
EU	EMA	Annex I: Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) (EMA/194159/2023)	Final	Clinical Trials, Compliance
EU	EMA	Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS (version 2.1)	Final	Clinical Trials, Compliance
EU	EMA	Guide on CTIS Common features: Overview of CTIS workspaces and common system functionalities - CTIS Training Programme (Module 02), Version 2.1	Final	Clinical Trials, Procedural
EU	EMA	Roles and permissions matrix summary: Authority Workspace - CTIS Training Programme ( Module 7), Version 2.24	Final	Clinical Trials, Procedural
EU	EMA	Step-by-step guide: Create, submit and withdraw a clinical trial application and non-substantial modifications - CTIS Training Programme (Module 10), Version 1.1	Final	Clinical Trials, Procedural
EU	EMA	FAQs: How to create, submit and withdraw a CTA - CTIS Training Programme (Module 10), Version 1.5	Final	Clinical Trials, Procedural
EU	EMA	Checklist of required fields per application type: How to create, submit and withdraw a CTA - CTIS Training Programme (Module 10), Version 1.2	Final	Clinical Trials, Procedural
EU	EMA	Step-by-step guide: How to respond to RFIs received during the evaluation of a CTA - CTIS Training Programme (Module 11), Version 1.1	Final	Clinical Trials, Procedural
EU	EMA	FAQs: How to respond to Requests for Information received during the evaluation of a Clinical Trial Application - CTIS Training Programme (Module 11), Version 1.4	Final	Clinical Trials, Procedural
EU	EMA	Questions and Answers on the 'OPEN' Framework (EMA/185522/2024)	Final	Application Process
EU	EMA	Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures	Final	Application Process, Procedural
EU	EMA	Fee Regulation working arrangements on fees and charges payable to the European Medicines Agency appliable from 1 January 2025	Final	Application Process, Procedural
EU	EMA	Appendix 1: Acceptable intakes established for N-nitrosamines (EMA/307633/2024 /Rev. 5)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality, Variations
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev. 139)	Final	Safety, Pharmacovigilance
EU	EMA	ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines (EMA/CHMP/ICH/295401/2023)	Final	Real World Data, Real World Evidence
EU	EMA	Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products (EMA/CHMP/BPWP/277622/2024 rev. 3)	Final	Product Information, Blood Products
EU	EMA	Guideline on the clinical investigation of recombinant and human plasma-derived factor IX products (EMA/CHMP/BPWP/144552/2009 rev. 2)	Final	Clinical, Medical, Blood Products
EU	EMA	Paediatric investigation plan (PIP) - Key elements guidance (EMA/283362/2012 Rev. 2)	Final	Clinical Trials, Pediatrics
EU	EMA	Questions and answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use (EMA/581345/2023 Rev. 1)	Final	Application Process, Supply, Procedural, Trade
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 123)	Final	Safety, Pharmacovigilance
EU	EMA	Qualification opinion for Centiloid measure of Amyloid PET to quantify brain amyloid deposition (EMADOC-1700519818-1200791)	Final	Clinical, Medical, Innovation, Biomarkers
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	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev. 108) [Track version]	Final	Procedural, Safety, Pharmacovigilance, Variations
EU	EMA	Template - Non-clinical studies GLP compliance (Annex to the cover letter for marketing authorisation applications), Revision 1.2	Final	Safety, Procedural, Application Process
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/285717/2024)	Final	Product Information, Procedural
EU	EMA	ICH M12 Guideline on drug interaction studies - Step 5 (EMA/CHMP/ICH/652460/2022)	Final	Clinical Pharmacology
EU	EMA	ICH M12 Guideline on drug interaction studies - Questions and answers (EMA/CHMP/ICH/227930/2024)	Final	Clinical Pharmacology
EU	EMA	Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when	Final	Administrative
EU	EMA	Template - Medicine shortage prevention plan (EMA/549304/2023)	Final	Supply, Distribution
EU	EMA	Template - Medicine shortage mitigation plan	Final	Supply, Distribution
EU	EMA	IRIS guide for applicants (How to create, submit and manage IRIS applications, for industry and individual applicants) (EMA/444925/2018), Version 3.2	Final	Procedural, Application Process, Inspections, Orphans, Rare Diseases
EU	EMA	Tailored scientific advice to support step-by-step development of new biosimilars	Final	Biosimilars
EU	EMA	New product information wording – Extracts from PRAC recommendations on signals Adopted at the 13-16 May 2024 PRAC (EMA/PRAC/222450/2024)	Final	Labeling, Product Information, Safety, Pharmacovigilance
Hong Kong	DoH	Enhancement of Screening Procedures for Applications for Registration of Pharmaceutical Products/Substances	Final	Application Process, Procedural
Hong Kong	DoH	Incentive Measures for Applications for Registration of Pharmaceutical Products under “1+” Mechanism	Final	Application Process, Procedural
Hong Kong	DoH	Template - Local Expert Assessment/Evaluation Report for Application for Registration of Pharmaceutical Product Containing New Chemical/Biological Entity for local unmet medical need for life-threatening or severely-debilitating disease(s) submitted under the “1+ mechanism	Final	Application Process, Procedural
Hong Kong	DoH	Regulation of Medical Gases as Pharmaceutical Products	Final	Application Process, Procedural
Hong Kong	DoH	Guidance Notes on Registration of Medical Gases	Final	Application Process, Procedural
Hong Kong	DoH	Guidance Notes on Manufacture, Wholesale, Storage and Transport of Medical Gases (Version 1.0)	Final	Manufacturing, GMP, Supply, Distribution
Hong Kong	DoH	Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong (Version 5.0)	Final	Manufacturing, GMP, Supply, Compliance
Hong Kong	DoH	Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity	Final	Application Process
Hong Kong	DoH	Import and Export of Dangerous Drugs Guidance Notes for Applicants	Final	Trade, Supply
Hong Kong	DoH	Guidance on Application for Licence for Manufacturer of Pharmaceutical Products	Final	Manufacturing. GMP
Hong Kong	DoH	Form - Application for registration as authorized person	Final	Manufacturing. GMP, Supply, Procedural
Hong Kong	DoH	Guidance on Application for Registration as Authorized Person Introduction	Final	Manufacturing. GMP, Supply, Procedural
Hong Kong	DoH	List of approved Continuing Professional Development Activities (for Pharmaceutical Manufacturers)	Final	Manufacturing, GMP, Procedural, Administrative
India	ICMR	Guidelines for Ethical Use of Leftover De-identified/ Anonymous Samples for Commercial Purpose	Final	Clinical Trials, Cellular and Gene Therapy, Advanced Therapies
Ireland	HPRA	Guide to Fees for Human Products (FIN-G0002-34) [Track version]	Final	Application Process, Procedural
Ireland	HPRA	Guide to Labels and Leaflets of Human Medicines (AUT-G0034-24) [Track version]	Final	Labeling, Product Information
Ireland	HPRA	Questions and Answers on the Windsor Framework and medicines for human use	Final	Labeling, Packaging, Supply, Procedural, Compliance
Japan	PMDA	Amendment of the Instructions for Electronic Package Inserts Regarding Results of Studies Using Medical Information Database [Provisional translation]	Final	Product Information
Japan	PMDA	Points to Consider for Describing the Results of Studies Using Medical Information Database in Electronic Package Inserts [Provisional translation]	Final	Product Information
Kenya	PPB	Biopharmaceutics Classification System (BCS) of Various Drug Substance (Revision 0), Published June 2024	Final	Quality, Safety, Efficacy, Generics, Clinical Trials
Malaysia	NPRA	Frequently Asked Questions (FAQs): Registration application submitted via Facilitated Registration Pathway (FRP)	Final	Application Process
Netherlands	CCMO	Rates for reviewing research with a medicinal product and research with a medical device	Final	Clinical Trials, Procedural
New Zealand	Medsafe	Guidelines on the Regulation of Therapeutic Products in New Zealand - Overview of regulation of therapeutic products (Edition 2.0)	Final	Application Process, Product Classification, Quality, Safety, Supply, Clinical Trials
Saudi Arabia	Saudi FDA	SFDA’s Guidance on the Equivalence of Topical Products (Version 1.0)	Final	Generics, Product Development, Bioequivalence
Singapore	HSA	Risk management plan (RMP)	Final	Safety, Pharmacovigilance
South Africa	SAHPRA	Requests for information related to selling of medicines	Draft	Safety, Pharmacovigilance, Compliance
South Africa	SAHPRA	ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information (v 3.0)	Final	Electronic Submissions
South Africa	SAHPRA	Template - Amendment Schedule to API Master File (APIMF) Holder (Revision 1.0)	Final	Quality, Safety, Efficacy, Application Process, Procedural
South Africa	SAHPRA	Template - Standardised content of letter of access in reference to API Master File (APIMF) record (Revision 2)	Final	Quality, Safety, Efficacy, Application Process, Procedural
South Africa	SAHPRA	Form - Submission of documents relating to an API Master File (APIMF) (Revision 2)	Final	Quality, Safety, Efficacy, Application Process, Procedural
Switzerland	Swissmedic	Form - New authorisation of human medicinal products (Version 9.0)	Final	Application Process
Switzerland	Swissmedic	Form - Variations and extensions HAM (Version 19.0)	Final	Application Process, Variations
Switzerland	Swissmedic	Ordinance 3 on Measures to Combat the Coronavirus (COVID-19) ceases to apply as of 30 June 2024	Final	Procedural
Switzerland	Swissmedic	Guidance document – SwissPAR (Version 4.0)	Final	Procedural
Switzerland	Swissmedic	Form - Confirmation electronic submission (Version 1.1)	Final	Clinical Trials
Switzerland	Swissmedic	Changes to declaration of goods for the export of medicinal products (including clinical trials) and narcotics made to the Federal Office for Customs and Border Security FOCBS	Final	Trade, Procedural
Switzerland	Swissmedic	Guidance document - Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (Version 5.0)	Final	Application Process, Procedural
Switzerland	Swissmedic	Directory Overview of documents to be submitted (Version 9)	Final	Application Process, Procedural
Switzerland	Swissmedic	Form - Order form for a CPP (Certificate of a Pharmaceutical Product)	Final	Manufacturing, Trade
Switzerland	Swissmedic	Form - Application for fee reduction for non-commercially funded clinical trials	Final	Clinical Trials
Switzerland	Swissmedic	Template - Application fee reduction self-declaration (for non-commercially funded clinical trials) (Version 1.0)	Final	Clinical Trials
Switzerland	Swissmedic	Guidance document - Formal requirements (Version 14.0)	Final	Procedural, Administrative, Application Process
Switzerland	Swissmedic	Information sheet - Archive access (Version 1.2)	Final	Administrative, Procedural
Switzerland	Swissmedic	Information sheet - eIAM Portal Administrator (Version 3.0)	Final	Administrative, Procedural, Clinical Trials
Switzerland	Swissmedic	Form - Declaration by the Responsible Person for foreign manufacturers (Version 2.2)	Final	Manufacturing, GMP, Quality, Compliance, Procedural
Tanzania	TMDA	Tanzania Medicines and Medical Devices (Fees and charges) (Amendment) Regulations, 2024	Draft	Application Process, Procedural
Tanzania	TMDA	Guidelines for good storage and distribution practices of pharmaceutical products (TMDA/DMC/CIE/G/000)	Final	Distribution
Tanzania	TMDA	Notice of revocation of marketing authorization for medicinal products containing ampicillin active ingredient as monotherapy	Final	Efficacy, Antimicrobial, Compliance
UK	MHRA	International Recognition Procedure	Final	Application Process
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
US	FDA	M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines	Draft	Real World Data, Real World Evidence
US	FDA	Considerations in Demonstrating Interchangeability With a Reference Product: Update - Guidance for Industry	Draft	Biosimilars
US	FDA	Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products - Draft Guidance for Industry	Draft	Combination Products
US	FDA	Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies - Guidance for Industry	Draft	Clinical Trials
US	FDA	Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions - Draft Guidance for Industry	Draft	Electronic Submissions, Inspections
US	FDA	Processes and Practices Applicable to Bioresearch Monitoring Inspections - Guidance for Industry	Draft	Inspections
US	FDA	Facility Readiness: Goal Date Decisions Under GDUFA - Guidance for Industry	Final	Generics, Inspections
US	FDA	Diabetic Foot Infections: Developing Drugs for Treatment - Guidance for Industry	Final	Clinical, Medical, Antimicrobial
US	FDA	Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics - Guidance for Industry	Final	Clinical, Medical
US	FDA	Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection - Guidance for Industry	Final	Inspections, Compliance
Zimbabwe	MCAZ	Form - Application for an import permit	Final	Trade, Procedural

Global Pharma Guidance Tracker – June 2024

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