Country	Organization	Document	Status	Category
International (Australia, Canada, Singapore, Switzerland, UK)	ACCESS Consortium	Access Consortium Good Manufacturing Practice (GMP) Statement	Final	Manufacturing, GMP, Inspections
International	PIC/S-EMA	Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems (EMA/INS/GMP/778340/2022) (PS/INF 94/2022)	Draft	GMP, Manufacturing, Quality
Australia	TGA	Potential reforms to the regulation of nicotine vaping products	Draft	Quality, Safety, Supply
Australia	TGA	International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names	Draft	Labeling, Prescribing, Safety
Australia	TGA	Authorised Prescriber Scheme - Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors (Version 5.2)	Final	Compassionate Use
Australia	TGA	Special Access Scheme	Final	Compassionate Use
Canada	HC	Draft (Step 2) ICH Guideline, Technical Specification, and Template M11: Clinical electronic Structured Harmonised Protocol (CeSHarP)	Draft	Clinical Trials
Canada	HC	The Regulatory Enrolment Process (REP): Drugs for Human/ Veterinary Use and Disinfectants (Available on request from Health Canada)	Final	Procedural, Application Process
Canada	HC	Notice to stakeholders: Health Canada's expectations regarding risk-management measures for clinical trials involving psychedelic-assisted psychotherapy	Final	Clinical Trials
Denmark	DMA	Change of practice for the Danish Medicines Agency’s inspections	Final	Inspections, Procedural, Administrative
EU	OCABR (EDQM)	Guideline for Pandemic COVID-19 Vaccine, Inactivated	Final	Vaccines
EU	EC	Commission notice - Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another	Final	Orphans, Rare Diseases, Procedural, Application Process
EU	HMA/EMA	Launch of phase 2 of the Simultaneous National Scientific Advice pilot (EMA/903809/2022)	Final	Application Process, Innovation, Procedural
EU	HMA/EMA	Guidance for applicants on Simultaneous National Scientific Advice (SNSA) phase 2 pilot (from October 2022) – Optimized process (EMA/896928/2022)	Final	Application Process, Innovation, Procedural
EU	HMA/EMA	Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and content (EMA/896929/2022)	Final	Application Process, Innovation, Procedural
EU	HMA/EMA	List of NCA’s participating in the Simultaneous National Scientific Advice (SNSA) pilot phase 2 (EMA/896931/2022)	Final	Application Process, Innovation, Procedural
EU	HMA/EMA	Application form to request a Simultaneous National Scientific Advice (SNSA) (EMA/896930/2022)	Final	Application Process, Innovation, Procedural
EU	HMA	Best Practice Guide for Sponsors of document naming in CTIS	Final	Clinical Trials
EU	CMDh	Q&A on Active Substance master file (ASMF) (CMDh/CMDv/280/2012, Rev.12) [Track version]	Final	Quality, GMP, Manufacturing, Variations
EU	CMDh	HaRP Assessment Report template (EMA/CMDh/438/2022, Rev. 1)	Final	Procedural, Safety, Pharmacovigilance
EU	CMDh	Template for the notification of step 2 confirmatory testing outcome: confirmation of nitrosamine detected (CMDh/409/2019, Rev.5)	Final	Safety, Pharmacovigilance, Manufacturing, GMP, Quality
EU	EMA	Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances (EMA/CHMP/CMDh/CAT/BWP/828612/2022)	Draft	Biologics, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	Concept paper on platform trials (EMA/CHMP/840036/2022)	Draft	Clinical Trials
EU	EMA	New product information wording – Extracts from PRAC recommendations on signals Adopted at the 24-27 October 2022 PRAC	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	ICH guideline E8 (R1) on general considerations for clinical studies (EMA/CHMP/ICH/544570/1998 Cor)	Final	Clinical Trials, Efficacy
EU	EMA	Minimum inhibitory concentration (MIC) breakpoints (EMA/916812/2022)	Final	Clinical, Antimicrobial
EU	EMA	Clinical Trials Information System (CTIS) - Sponsor Handbook (EMA/902230/2022 – v. 3.00)	Final	Clinical Trials, Procedural
EU	EMA	Step-by-step guide: Management of roles and permissions: High-level Administrator registration - CTIS Training Programme: Module 07 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	FAQs: Management of roles and permissions - CTIS Training Programme: Module 7 (Version 1.3)	Final	Clinical Trials, Procedural
EU	EMA	Roles and permissions matrix summary: Sponsors Workspace - CTIS Training Programme: Module 7 (Version 2.29)	Final	Clinical Trials, Procedural
EU	EMA	Letter of support for Neurofilament light in childhood neurological diseases (EMADOC-1700519818-959805)	Final	Pediatrics, Clinical, Medical
EU	EMA	Letter of support for a Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studies in Parkinson’s Disease (EMADOC-1700519818-955717)	Final	Clinical Trials
EU	EMA	Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections (EMA/INS/PhV/773932/2022 – Rev 01)	Final	Inspections, Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 105)	Final	Safety, Pharmacovigilance
EU	EMA	ICH guideline Q3C (R8) on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006 Corr)	Final	Quality, Safety, Manufacturing, GMP
EU	EMA	Scientific Advice on medicines for Human use in the EU medicines regulatory network	Final	Application Process
EU	EMA	IRIS guide to registration and RPIs - Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration (Version 2.10)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/890290/2022)	Final	Product Information, Procedural
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (EMA/136146/2012, Rev.22)	Final	Safety, Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (EMA/136157/2012, Rev.32)	Final	Safety, Pharmacovigilance
EU	EMA	EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (EMA/136156/2012, Rev.63)	Final	Safety, Pharmacovigilance
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.52)	Final	Procedural, Compliance, Administrative
EU	EMA	Dates of 2023 SAWP meetings and submission deadlines - Scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests (EMA/569289/2019 Rev.3)	Final	Application Process, Procedural, Administrative
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.120)	Final	Safety, Pharmacovigilance
EU	EMA	Template for the notification of step 2 confirmatory testing outcome: confirmation of nitrosamine detected	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	EMA	Template - Statement of quantitative composition	Final	Procedural
EU	EMA	Procedural advice for orphan medicinal product designation - Guidance for sponsors (EMA/420706/2018 Rev 12)	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) (EMA/749945/2015 Rev. 3)	Final	Product Information, Labeling, Variations
EU	EMA	Anonymisation of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) - General guidance (EMA/781194/2021)	Final	Safety, Pharmacovigilance, Procedural
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev. 100) [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
Finland	Tukija	Documents mentioned in the annex I of the Clinical Trial Regulation (536/2014) and other relevant documents regarding the assessment of the part II of the application dossier	Final	Clinical Trials
Finland	Tukija	Instructions On Reporting Financial and Other Arrangements Related to Clinical Trials (CTR 536/2014)	Final	Clinical Trials
India	CDSCO	Draft policy for approval of new drugs	Draft	Application Process
India	CDSCO	New Drugs and Clinical Trials Rules, 2019 - General Statutory Rule (GSR) 835(E) - Amendment in First Schedule for non-clinical testing methods for new drugs (Pluripotent)	Draft	Clinical Trials, Safety, Efficacy
India	CDSCO	Final General Statutory Rule (GSR) 823(E) - Amendment in rule 96 for mandating Bar or QR code on the label of top 300 brand in Drugs Rules	Final	Labeling, Packaging, Supply, Distribution
India	CDSCO	Final General Statutory Rule (GSR) 778(E) - Insertion of Provisions for deemed approvals in various rules under NDCTR 2019	Final	Clinical Trials
Lithuania	SMCA Lithuania	Legislation of the "grace period"	Final	Labeling, Packaging
Lithuania	SMCA Lithuania	Available Slots for RMS procedures in 2023	Final	Application Process
New Zealand	Medsafe	Changed medicine notification - Form A	Final	Variations
New Zealand	Medsafe	Changed medicine notification - Form B	Final	Variations
Pakistan	DRAP	Post Registration Variation Guidelines for Pharmaceutical and Biological Products (PE&R/GL/PV/01), 1^st Edition	Final	Variations
Philippines	FDA Philippines	Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration	Draft	Application Process, Clinical Trials, Manufacturing, Inspections, Safety, Pharmacovigilance
Philippines	FDA Philippines	Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National Public Health Emergencies	Draft	Application Process, Procedural
Saudi Arabia	Saudi FDA	Regulations and Requirements for Conducting Clinical Trials on Drugs (Version 2.3)	Final	Clinical Trials
Saudi Arabia	Saudi FDA	Guideline on good pharmacovigilance practices (GVP) (Version 3)	Final	Safety, Pharmacovigilance
Saudi Arabia	Saudi FDA	Guidance on Publication of Public Assessment Reports for Medicinal Products for Human Use (Saudi-PAR) (Version 1)	Final	Procedural
Saudi Arabia	Saudi FDA	Guidance for Graphic Design of Medication Packaging (Version 3.1)	Final	Packaging, Safety, Procedural
Saudi Arabia	Saudi FDA	Conditional Approval for Medicinal Products for Human Use (Version 1)	Final	Application Process
Saudi Arabia	Saudi FDA	Guideline on Blood Products (Plasma Derived Medicinal Products) (Version 1.1)	Final	Blood Products
Saudi Arabia	Saudi FDA	Guidance for the Preparation of a Site Master File (SMF) (Version 3.1)	Final	Manufacturing, GMP, Safety, Application Process
Saudi Arabia	Saudi FDA	Form – Drug Master File (Restricted Part)	Final	Application Process, Procedural
South Africa	SAHPRA	Guideline for the API Master File (APIMF) procedure (SAHPGL-PEM-03), Version 3	Final	Quality, Safety, Efficacy, Application Process, Procedural
South Africa	SAHPRA	Guideline for cultivation of cannabis and manufacture of cannabis-related pharmaceutical products for medicinal and research purposes (SAHPGL-INSP-RC-13), Version 3	Final	GMP, Manufacturing
South Africa	SAHPRA	Guideline on how to lodge a complaint on medicines and medical devices (SAHPGL-INSP-RC-12), Version 4	Final	Procedural, Safety
Switzerland	Swissmedic	Guidance on the Submission Process for Clinical Trials with Medicinal Products	Final	Clinical Trials, Procedural
Switzerland	Swissmedic	Information sheet - Instructions for filling the eDok_KLV folder structure	Final	Clinical Trials, Procedural
Switzerland	Swissmedic	Information sheet - Quick instruction for use of the FO submission form	Final	Clinical Trials, Procedural
Switzerland	Swissmedic	Working instructions - Guideline Amendments Clinical Trials: Instructions for submitting changes and for reporting during the course of a clinical trial	Final	Clinical Trials, Procedural
Switzerland	Swissmedic	Working instructions - Clinical Trial Application Dossier	Final	Clinical Trials, Procedural
Switzerland	Swissmedic	Working instructions – Guideline: Temporary Authorisation to Use an Unauthorised Medicinal Product	Final	Compassionate Use, Clinical Trials
Switzerland	Swissmedic	Out-of-Stock – COVID-19 – Authorisations for the temporary import and distribution of human medicines – Update	Final	Trade, Supply, Distribution
Switzerland	Swissmedic	M11: Clinical electronic Structured Harmonised Protocol (CeSHarP)	Draft	Clinical Trials
Switzerland	Swissmedic	Q5A(R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin	Draft	Quality, Safety
UK	MHRA	MHRA phase I accreditation scheme	Final	Clinical Trials
UK	MHRA	Project Orbis	Final	Application Process, Oncology, Procedural
UK	MHRA	European Commission (EC) Decision Reliance Procedure	Final	Procedural, Application Process
UK	MHRA	Medicines: notes for applicants and holders of a wholesale dealer licence or broker registration	Final	Procedural, Trade, Supply, Distribution
UK	MHRA	Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
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	Application of the Falsified Medicines Directive: Safety Features in Northern Ireland	Final	Packaging, Labeling, Safety
UK	MHRA	Clinical trials for medicines: manage your authorisation, report safety issues	Final	Clinical Trials
UK	MHRA	Guidance on the licensing of biosimilar products	Final	Biosimilars
UK	MHRA	Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines	Final	Application Process
US	FDA	E19: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials - Guidance for Industry	Final	Clinical Trials, Safety
US	FDA	Statistical Approaches to Establishing Bioequivalence - Guidance for Industry	Draft	Generics, Bioequivalence
US	FDA	ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions - Guidance for Industry	Draft	Generics
US	FDA	Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act	Final	Clinical, Antimicrobial
US	FDA	Sameness Evaluations in an ANDA — Active Ingredients: Guidance for Industry	Draft	Generics
US	FDA	Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin	Draft	Quality, Safety
US	FDA	M10: Bioanalytical Method Validation and Study Sample Analysis - Guidance for Industry	Final	Clinical, Medical
US	FDA	Cross Labeling Oncology Drugs in Combination Regimens - Guidance for Industry	Final	Clinical, Medical, Oncology
US	FDA	S1B(R1): Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals - Guidance for Industry	Final	Safety
US	FDA	Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program - Guidance for Industry	Draft	User Fee, Procedural
US	FDA	Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies - Guidance for Industry	Final	Clinical, Antimicrobial
US	FDA	Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial - Guidance for Industry	Final	Clinical Trials, Cellular and Gene Therapy, Advanced Therapies
US	FDA	Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers - Guidance for Industry	Draft	Procedural, Compassionate Use
US	FDA	Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for Industry	Final	Tissue Products, Cellular and Gene Therapy, Advanced Therapies
US	FDA	Draft Guidance on Ammonium Lactate – Topical (Cream)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ammonium Lactate – Topical (Lotion)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Budesonide – Oral (Capsule, Delayed Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Calcitonin Salmon – Injection (Injectable)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clindamycin Phosphate – Vaginal (Gel)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Deferiprone – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Drospirenone; Estetrol – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Eteplirsen – Intravenous (Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fidaxomicin – Oral (For Suspension)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fosdenopterin Hydrobromide – Intravenous (Powder)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Hydrocortisone – Rectal (Enema)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Hydroxyurea – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Inotersen Sodium - Subcutaneous (Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ketotifen fumarate – Ophthalmic (Solution/Drops)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Magnesium Sulfate; Potassium Chloride; Sodium Sulfate – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Melphalan Flufenamide Hydrochloride – Intravenous (Powder)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Miconazole Nitrate; White Petrolatum; Zinc Oxide – Topical (Ointment)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Mometasone Furoate – Nasal (Spray, Metered)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Nicardipine Hydrochloride – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Omeprazole Magnesium – Oral (Capsule, Delayed Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Patisiran Sodium – Intravenous (Solution)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ponesimod – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ranolazine – Oral (Granules, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tepotinib Hydrochloride – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Tivozanib Hydrochloride – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Triamcinolone Acetonide - Intra-Articular (For Suspension, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Trilaciclib Dihydrochloride – Intravenous (Powder)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Varenicline Tartrate – Nasal (Spray)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Voclosporin – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Acyclovir – Buccal (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Baricitinib – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Calcium Carbonate; Famotidine; Magnesium Hydroxide – Oral (Tablet, Chewable)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Daunorubicin Citrate – Injection (Injectable, Liposomal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Deferiprone – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ethinyl Estradiol; Norethindrone Acetate – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ferric Oxyhydroxide – Injection (Injectable) (EQ 62.5 mg iron/5 mL)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ferric Oxyhydroxide – Injection (Injectable) (EQ 100 mg iron/2 mL)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Goserelin acetate – Implantation (Implant) (EQ 10.8 mg base)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Goserelin acetate – Implantation (Implant) (EQ 3.6 mg base)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Icosapent Ethyl – Oral (Capsule)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Lapatinib Ditosylate – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Lidocaine – Topical (Patch)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Oxycodone – Oral (Capsule, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Progesterone – Vaginal (Gel)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ranolazine – Oral (Tablet, Extended Release)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Rifaximin – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate – Oral (Tablet)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Sumatriptan Succinate – Subcutaneous (Injectable, Vial)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Sumatriptan Succinate – Subcutaneous (Injectable, Autoinjector)	Draft	Generics, Product Development
Zimbabwe	MCAZ	Reliance guidelines for regulation of medicines (MCAZ/EVR/GL-04)	Final	Application Process, Procedural
Zimbabwe	MCAZ	Requirements for an application for a premises licence/wholesale dealers permit (LEF 92)	Final	Trade, Supply, Distribution
Zimbabwe	MCAZ	Form - Sample Submission (SR 06)	Final	Quality, Procedural

Global Pharma Guidance Tracker – November 2022

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