Country	Organization	Document	Status	Category
International	WHO	FAQ: Variations to prequalified pharmaceutical products	Final	Variations
International	WHO	Application Form - Variation to a Prequalified Finished Pharmaceutical Product (FPP)	Final	Variations
International	WHO	Nitrosamine contamination policy for FPP applications	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality, Variations
International	WHO	Recommended comparator products: Neglected Tropical Diseases	Final	Clinical Trials, Clinical, Medical
International	WHO	Form or Template - Presentation of bioequivalence trial information	Final	Procedural, Bioequivalence
International	WHO	Guidance on Bioequivalence Studies for Reproductive Health Medicines	Final	Generics, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Benzathine benzylpenicillin	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Azithromycin	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Desogestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Ethinylestradiol/Desogestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Ethinylestradiol/Levonorgestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Levonorgestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Medroxyprogesterone acetate	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Medroxyprogesterone acetate/Estradiol Cypionate	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Mifepristone	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Misoprostol	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Norethisterone	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Norethisterone enanthate	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Norethisterone enanthate/Estradiol valerate	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Norgestrel	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Procaine benzylpenicillin	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Sofosbuvir	Final	Generics, Product Development, Bioequivalence
International	WHO	Notes on the Design of Bioequivalence Study: Ulipristal acetate	Final	Generics, Product Development, Bioequivalence
International	ICH	M13A: Bioequivalence for immediate release solid oral dosage forms	Draft	Bioequivalence
International (Australia, Canada, Singapore, Switzerland, UK)	ACCESS Consortium	Operational procedures for the Generic Medicines Work-Sharing Initiative (GMWSI)	Final	Application Process, Generics
International (Australia, Canada, Singapore, Switzerland, UK)	ACCESS Consortium	Generic Medicines Work Sharing Initiative (GMWSI) - Expression Of Interest (EOI) Form	Final	Application Process, Procedural, Generics
Australia	TGA	Proposed amendments to the Poisons Standard - ACMS, ACCS and joint ACMS-ACCS meetings, March 2023	Draft	Safety, Compliance, Product Classification, Prescribing
Australia	TGA	Application to amend the Poisons Standard	Final	Product Classification, Procedural
Australia	TGA	Communicating about COVID-19 vaccines	Final	Advertising, Promotion, Vaccines
Australia	TGA	Therapeutic goods that contain or are produced from human blood or plasma	Final	Blood Products
Australia	TGA	Adventitious agent safety of medicines	Final	Safety, Manufacturing, GMP, Quality
Australia	TGA	Dossier requirements for Class 2, 3 and 4 biologicals	Final	Biologicals
Australia	TGA	Notification of a new proprietary ingredient	Final	Procedural
Australia	TGA	Changes to the Permissible Ingredients Determination	Final	Safety, Compliance
Canada	HC	Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19	Final	Procedural, Compliance
Canada	HC	Draft guidance on advanced therapeutic products framework	Draft	Cellular and Gene Therapy, Advanced Therapies
Canada	HC	Draft guidance document on terms and conditions (T&Cs) for human and veterinary drugs	Draft	Safety, Pharmacovigilance, Compliance
Canada	HC	Draft guidance on management of rolling reviews for drug submissions	Draft	Application Process
Canada	HC	Draft guidance document on the collection and analysis of disaggregated data in clinical trials	Draft	Clinical Trials
Canada	HC	Biologic drugs (Schedule D drugs) – Division 4 proposed regulatory amendments: Notice to stakeholders	Draft	Biologics
Canada	HC	Guidance on the Food and Drug Regulations for public health emergency drugs	Draft	Application Process
Canada	HC	Draft guidance document: Labelling of pharmaceutical drugs for human use	Draft	Labeling
Canada	HC	Quality (chemistry and manufacturing) draft guidance: New Drug Submissions and Abbreviated New Drug Submissions	Draft	Quality, Chemistry, Manufacturing and Controls, CMC
Canada	HC	Submitting risk management plans draft guidance document	Draft	Safety, Pharmacovigilance
Croatia	HALMED	Obligation to submit a variation application following PSUSA procedure	Final	Variations, Product Information
Denmark	DMA	Updating of summaries of product characteristics due to changed ATC codes for 2023	Final	Product Information
Denmark	DMA	Danish Drug Standards	Final	Quality, Safety, Efficacy
Denmark	DMA	Guidelines for submission and technical validation of applications	Final	Application Process, Variations
Denmark	DMA	Fees payable for medicinal products and companies	Final	Application Process, Procedural
Denmark	DMA	Fees for clinical trials	Final	Clinical Trials, Procedural
Denmark	DMA	End of trial notification and publication of results	Final	Clinical Trials
Denmark	DMA	Wholesalers must not receive or buy medicines from non-EU/EEA countries (third countries) nor handle intermediate products	Final	Trade, Supply
Denmark	DMA	Guidelines on applications for authorisation to wholesale distribute medicines within the EEA	Final	Trade, Supply
Denmark	DMA	Practice when applying for a change in the legal status of a human medicinal product	Final	Switching, Product Classification
Denmark	DMA	Danish translations of product information	Final	Product Information
Denmark	DMA	Requirements and expectations for the qualified person in a pharmaceutical company	Final	Quality, Manufacturing, GMP
Denmark	DMA	Q&A about safety features on the packaging of medicinal product	Final	Safety, Labeling
Denmark	DMA	Guideline on variations to marketing authorisations for medicinal products for human use	Final	Variations
Denmark	DMA	Guideline for applications for authorisation of clinical trials of medicinal products in humans	Final	Clinical Trials
EU	EDQM	Certification of suitability to the Monographs of the European Pharmacopoeia - Management of CEP guidelines and operational documents for the CEP procedure (PA/PH/CEP (22) 44)	Final	Procedural, Quality, Manufacturing, GMP
EU	EC	Clinical Trials Regulation (EU) No 536/2014 - Questions & Answers (Version 6.3)	Final	Clinical Trials
EU	EC	Recommendation paper on decentralised elements in clinical trials (Version 01)	Final	Clinical Trials
EU	EC	Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006	Final	Clinical Trials
EU	CMDh	Best Practice Guides (BPGs) Chapter 2 – Procedure for Automatic Validation of Mutual Recognition Procedures for Variations (CMDh/292/2013/Rev.21) [Track version]	Final	Variations
EU	CMDh	Chapter 3 - CMDh Best Practice Guide for the processing of Type IA minor variations (notifications) in the Mutual Recognition Procedure (CMDh/293/2013/Rev.25) [Track version]	Final	Variations
EU	CMDh	Chapter 4 - CMDh Best Practice Guide for the processing of Type IB minor variations (notifications) in the Mutual Recognition Procedure (CMDh/294/2013, Rev. 26) [Track version]	Final	Variations
EU	CMDh	Chapter 5 – CMDh Best Practice Guide for the handling of Type II variations in the Mutual Recognition Procedure (CMDh/295/2013, Rev.25) [Track version]	Final	Variations
EU	CMDh	Chapter 6 - CMDh Best Practice Guide for the processing of grouped applications in the Mutual Recognition Procedure (CMDh/296/2013 Rev. 25) [Track version]	Final	Variations
EU	CMDh	Chapter 7 - CMDh Best Practice Guide on Variation Worksharing (CMDh/297/2013/Rev.30) [Track version]	Final	Variations
EU	CMDh	Cover letter for Variation Applications in the Mutual Recognition Procedure (CMDh/096/2009, Rev.6)	Final	Variations
EU	CMDh	CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures (CMDh/004/2005, Rev.19) [Track version]	Final	Application process, Procedural
EU	CMDh	CMDh position paper concerning Applicants request of submission of multiple applications during ongoing Decentralised Procedures or inclusion of new CMS or additional strength(s) in an already ongoing Decentralised Procedure (DCP) (CMDh/271/2012, Rev.2) [Track version]	Final	Application process, Procedural
EU	CMDh	Decentralised Procedure - Applicant's (joint) response template (CMDh/436/2022 Rev.1)	Final	Application process, Procedural
EU	CMDh	Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (CMDh/341/2015 Rev.2)	Final	Intellectual Property
EU	CMDh	Q&A on Active Substance master file (ASMF) (CMDh/CMDv/280/2012, Rev.12) [Track version]	Final	Quality, Safety, Procedural
EU	CMDh	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/409815/2020 Rev.14)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality
EU	EMA	Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice (EMA/INS/GMP/258937/2022)	Final	Clinical Trials, Manufacturing, GMP, Quality
EU	EMA	Guidance for the conduct of good clinical practice inspections – Phase I units (EMA/786433/2022)	Final	Clinical Trials, Inspections, Compliance
EU	EMA	Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA (EMA/274221/2021), Version: 3.1	Final	Inspections, Compliance, Manufacturing, GMP, Clinical Trials, Safety, Pharmacovigilance
EU	EMA	Validation Checklist for Type II (non)clinical variations	Final	Variations
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev. 101) [Track version]	Final	Procedural, Safety, Pharmacovigilance, Variations
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	New Organization First User QPPV/RP or Change of EU QPPV/RP (EMA/503895/2018)	Final	Safety, Pharmacovigilance
EU	EMA	EudraVigilance registration documents (EMA/503894/2018)	Final	Safety, Pharmacovigilance
EU	EMA	Clinical Trials Information System (CTIS) - Sponsor Handbook (EMA/923413/2022 – v. 3.01)	Final	Clinical Trials, Procedural
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.121)	Final	Safety, Pharmacovigilance
EU	EMA	Letter of Support of Model-based Clinical Trial Simulation Platform (CTSP) for Duchenne Muscular Dystrophy (EMADOC-1700519818-955047)	Final	Clinical Trials, Medical, Innovation
EU	EMA	IRIS guide to registration and RPIs - Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration (Version 2.11)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	IRIS guide for Parallel Distribution applicants (EMA/805961/2018)	Final	Trade, Procedural, Application Process
EU	EMA	Qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients (EMADOC-1700519818-946771)	Final	Clinical Trials, Medical, Innovation
EU	EMA	Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg – Product-specific bioequivalence guidance (EMA/CHMP/559891/2021)	Final	Generics, Product Development, Bioequivalence
EU	EMA	Liposomal amphotericin B powder for dispersion for infusion 50 mg - Product-specific bioequivalence guidance (EMA/CHMP/559889/2021)	Final	Generics, Product Development, Bioequivalence
EU	EMA	Q&A: Good clinical practice	Final	Clinical Trials
EU	EMA	Clinical pharmacology and pharmacokinetics: questions and answers	Final	Quality, Safety, Efficacy, Pharmacology
EU	EMA	eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual (EMA/308954/2012), Version 5.8	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training Frequently asked questions (EMA/344287/2016, Rev. 2)	Final	Safety, Pharmacovigilance
EU	EMA	Vendor registration in the EudraVigilance external compliance testing environment (XCOMP) (EMA/382824/2017)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Template or form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance	Final	Safety, Pharmacovigilance
EU	EMA	EMA EudraVigilance Registration Manual (EMA/13454/2020, Rev. 13)	Final	Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 106)	Final	Safety, Pharmacovigilance
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/932646/2022)	Final	Product Information, Procedural
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.53)	Final	Procedural, Compliance, Administrative
EU	EMA	Letter of support for TREAT-NMD Core Dataset for Spinal Muscular Atrophy (SMA) (EMADOC-1700519818-958775)	Final	Innovation, Real World Data, Real World Evidence
India	CDSCO	Inspection/Audits of Pharmacovigilance (PV) system of importers and manufactures of human vaccine	Final	Inspections, Vaccines, Safety, Pharmacovigilance
Ireland	HPRA	Guide to Fees for Human Products (FIN-G0002-30) [Track version]	Final	Application Process
Ireland	HPRA	Fee Application Form for Human Products	Final	Application Process, Procedural
Ireland	HPRA	Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs (including the import of cannabis products) (AUT-G0127-8) [Track version]	Final	Trade
Ireland	HPRA	Adverse Reaction Report Form For COVID-19 Vaccines	Final	Safety, Pharmacovigilance, Vaccines
Ireland	HPRA	Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products (AUT-G0070-5) [Track version]	Final	Switching, Product Classification
Ireland	HPRA	Form - Batch-Specific Requests for Human Medicines	Final	Supply, Quality
Lithuania	SAM Lithuania	Available Slots for RMS procedures in 2023	Final	Application Process, Procedural
Netherlands	CCMO	Patient participation in the research file from 1 March 2023	Final	Clinical Trials
Netherlands	MEB	Changes to fees for human medicinal products and devices as of 1 January 2023	Final	Application Process
Pakistan	DRAP	Good manufacturing practices (QALT/GL/MP/004), 1st Edition	Draft	Manufacturing, GMP
Pakistan	DRAP	Reliance Mechanism In Regulatory Processes “DRAP Approach on Good Reliance Practice” (QMSC/GL/RM/005)	Final	Application Process, Clinical Trials, Manufacturing, Inspections, Safety, Pharmacovigilance
Philippines	FDA Philippines	Updated Guidelines on Frontline Services of the Food and Drug Administration (FDA) in the New Normal	Draft	Administrative
Slovakia	SIDC Slovakia	Registration - Change of application submitting procedure from 1.1.2023	Final	Application Process
Slovakia	SIDC Slovakia	Submission of applications	Final	Application Process
Slovakia	SIDC Slovakia	Procedure for submitting registration documentation to SIDC	Final	Application Process
Switzerland	Swissmedic	Position Paper on decentralised clinical trials (DCTs) with medicinal products in Switzerland (Version 2.0)	Final	Clinical Trials
Switzerland	Swissmedic	Guidance document - Temporary authorisation for human medicinal products HMV4	Final	Application Process, Procedural
Switzerland	Swissmedic	Information Sheet - Individual import licence for immunological medicinal products, blood or blood products	Final	Blood Products, Procedural
Switzerland	Swissmedic	Information sheet - Swissmedic eGov Portal –OCABR standard functions	Final	Application Process, Procedural
Switzerland	Swissmedic	Guidance document - Time limits for authorisation applications HMV4	Final	Application Process, Procedural
Switzerland	Swissmedic	Guidance document - Description of document protection HMV4	Final	Procedural, Administrative
Switzerland	Swissmedic	Guidance document - Product information for human medicinal products HMV4	Final	Product Information, Labeling
Switzerland	Swissmedic	Guidance document - SwissPAR HMV4	Final	Procedural
Switzerland	Swissmedic	Form - New authorisation of human medicinal products HMV4	Final	Application Process, Procedural
Switzerland	Swissmedic	Form - Decision minutes: Accelerated Application Hearing HMV4	Final	Application Process, Procedural, Administrative
Switzerland	Swissmedic	Guidance document - Variations and extensions HAM HMV4	Final	Variations
Switzerland	Swissmedic	Form - Variations and extensions HAM HMV4	Final	Variations, 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	Guidance document - Formal requirements HMV4	Final	Combination Products, Application Process
Switzerland	Swissmedic	Information sheet - Guidance on the Submission Process for Clinical Trials with Medicinal Products	Final	Clinical Trials, Application Process
Switzerland	Swissmedic	Guideline - Temporary Authorisation to Use an Unauthorised Medicinal Product	Final	Compassionate Use, Clinical Trials
Switzerland	Swissmedic	Division Laboratories (OMCL) Official Control Authority Batch Release	Final	Procedural, Manufacturing, GMP, Supply, Quality
Switzerland	Swissmedic	OMCL - Request for batch release	Final	Supply, Quality
Switzerland	Swissmedic	OMCL - Request for testing of plasma pool	Final	Procedural, Manufacturing, GMP, Blood Products, Quality
Switzerland	Swissmedic	OMCL - Marketing Information Form	Final	Procedural, Manufacturing, GMP
Switzerland	Swissmedic	Information sheet - Instructions for filling the eDok_KLV folder structure	Final	Clinical Trials, Procedural
Tanzania	TMDA	Notice - Checklist for screening of applications for registration of human medicinal products before their submission	Final	Application Process
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
UK	MHRA	Innovation Accelerator	Final	Application Process, Procedural, Innovation
UK	MHRA	Medicines: apply for a parallel import licence	Final	Procedural, Trade
US	FDA	Format and Content of a REMS Document - Guidance for Industry	Final	Safety, Pharmacovigilance
US	FDA	REMS Document Technical Conformance Guide - Technical Specifications Document	Final	Safety, Pharmacovigilance
US	FDA	M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)	Draft	Clinical Trials
US	FDA	M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)	Draft	Clinical Trials
US	FDA	M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)	Draft	Clinical Trials
US	FDA	Controlled Correspondence Related to Generic Drug Development	Draft	Generics
US	FDA	Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims - Guidance for Industry	Final	Labeling
US	FDA	Pulmonary Tuberculosis: Developing Drugs for Treatment	Draft	Clinical, Antimicrobial
US	FDA	Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe - Guidance for Industry	Final	Generics
US	FDA	Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations	Draft	Clinical, Medical
US	FDA	Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection - Guidance for Industry	Draft	Compliance, Inspection, Procedural
US	FDA	Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria - Guidance for Industry	Final	Blood Products
US	FDA	Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer - Guidance for Industry	Final	Clinical, Pharmacology, Oncology
Zimbabwe	MCAZ	Evaluations and registration division - Document Submission Checklist	Final	Application Process

Global Pharma Guidance Tracker – December 2022

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