Country	Organization	Document	Status	Category
International	WHO	WHO Guideline for the safe production and quality control of monoclonal antibodies and related products for use in humans (WHO/BS/2022.2414)	Draft	Biologics, Quality
International	IPRP	Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers	Final	Biosimilars
Australia	TGA	Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines (Version 4.0)	Draft	Safety, Application Process
Australia	TGA	Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process (Version 1.0)	Draft	Biologicals, Application Process
Australia	TGA	Special Access Scheme (SAS) online system guidance (Version 1.4)	Final	Compassionate Use
Belgium	FAMHP	Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market	Final	Clinical Trials, Procedural, Labeling
Canada	HC	Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations	Final	Clinical Trials
Canada	HC	Guidance on applications for COVID-19 drug clinical trials under the Regulations	Final	Clinical Trials
Canada	HC	Notice: Period reduced for keeping clinical trial records for drugs and natural health products	Final	Clinical Trials, Procedural
Canada	HC	Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice	Final	Trade, Supply, Distribution
Canada	HC	Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148)	Final	Trade, Supply, Distribution
Canada	HC	Drug shortages in Canada: Regulations and guidance	Final	Trade, Supply, Distribution
Canada	HC	Guidance document: preparation of regulatory activities in non-eCTD format	Final	Application Process, Procedural
Canada	HC	Regulatory Requirements for Drug Identification Numbers (DINs)	Final	Procedural
Czech Republic	SÚKL	CT Safety reporting	Final	Clinical Trials
Denmark	DMA	Allocation of time slots (DCP)	Final	Application Process, Procedural
Denmark	DMA	Questions and answers about the naming of medicines	Final	Procedural, Safety, Labeling
EU	EC	Annex 21 - Eudralex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (C(2022) 843)	Final	Manufacturing, GMP, Trade
EU	EC	Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA/CHMP/BWP/534898/2008 Rev. 2)	Final	Clinical Trials, Biologicals, Quality
EU	EC	Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA/CHMP/QWP/545525/2017 Rev. 2)	Final	Clinical Trials, Biologicals, Quality
EU	EC	Guidance on the Management of Clinical Trials During the Covid-19 (coronavirus) pandemic (version 5)	Final	Clinical Trials
EU	EC	Template - Compliance with Member State applicable rules for the collection, storage and future use of human biological samples (Article 7.1h)	Final	Clinical Trials, Procedural
EU	EDQM	Update of application forms for Certificate of Suitability applications	Final	Application Process, Procedural, Quality, Safety, Efficacy
EU	EDQM	EDQM remote inspections: from pilot phase to a permanent element of EDQM’s inspection scheme	Final	Inspections, Compliance, GMP, Quality
EU	CMDh	Applicant’s response document in Mutual Recognition and Decentralised procedures for Marketing Authorisation Applications (CMDh/091/2003, Rev.9) [Track version]	Final	Application Process, Procedural
EU	CMDh	CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008	Final	Variations
EU	CMDh	Chapter 8 - CMDh Best Practice Guide on CMDh recommendations on unforeseen variations (CMDh/298/2013, Rev.23) [Track version]	Final	Variations
EU	CMDh	RMS Validation Checklist for human medicinal products in DCP (CMDh/368/2017, Rev.5)	Final	Application Process, Procedural, Administrative
EU	CMDh	Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures (CMDh/085/2008, Rev.26) [Track version]	Final	Application Process, Procedural
EU	CMDh	Requirements on submissions for Variations and Renewals within MRP and National Procedures (CMDh/006/2008, Rev.26) [Track version]	Final	Variations, Procedural
EU	EMA	Clinical Trials Information System (CTIS) - Technical requirements for optimal use (EMA/121913/2022 - version 1.00)	Final	Clinical Trials, Procedural
EU	EMA	Guide on CTIS Common features - User Access Management CTIS Training Programme: Module 02 (Version 1.2)	Final	Clinical Trials, Procedural
EU	EMA	Template or form: Innovation Task Force (ITF) briefing meeting request form	Final	Procedural, Innovation
EU	EMA	FAQs: Overview of CTIS workspaces and common system functionalities - CTIS Training Programme: Module 2 (Version 1.2)	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.112)	Final	Safety, Pharmacovigilance
EU	EMA	Nullification ICSRs received by EudraVigilance	Final	Safety, Pharmacovigilance
EU	EMA	Safety Working Party recommendations on the duration of contraception following the end of treatment with a genotoxic drug (EMA/CHMP/SWP/74077/2020 corr. 3)	Final	Safety, Toxicology
EU	EMA	European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance (EMA/4260/2001 Rev. 12)	Final	Application Process, Procedural
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 97)	Final	Safety, Pharmacovigilance
EU	EMA	Qualification Opinion - Use of Enroll-HD (a Huntington’s disease patient registry) as a data source and infrastructure support for post-authorisation monitoring of medical products	Draft	Safety, Pharmacovigilance
EU	EMA	EudraVigilance - EVWEB User Manual (Version 1.6) (EMA/501718/2018)	Final	Safety, Pharmacovigilance, Procedural
EU	EMA	EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets	Final	Safety, Pharmacovigilance, Procedural
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.43)	Final	Procedural, Compliance, Administrative
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/106931/2022)	Final	Product Information, Procedural
EU	EMA	Member states contact points for translations review (EMA/102302/2005 v. 6.22)	Final	Procedural
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 2)	Final	Labeling, Packaging, Procedural
EU	EMA	Principal Documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP (EMA/30963/2022)	Final	Clinical Trials, Inspections, Compliance
EU	EMA	Clinical pharmacology and pharmacokinetics: questions and answers	Final	Quality, Safety, Efficacy
EU	EMA	Template - Translations required with the submission of an application for transfer of orphan medicinal product designation	Final	Procedural, Rare Diseases, Orphans
EU	EMA	Template - Translations required with the submission of an application for orphan medicinal product designation	Final	Procedural, Rare Diseases, Orphans
EU	EMA	IRIS guide to registration and RPIs - Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration (Version 2.8)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of Administration (RoA) (EMA/580321/2021)	Final	Administrative, Pharmacovigilance, Safety, Procedural
EU	EMA	EudraVigilance: Obtaining EDQM terms from SPOR (EMA/580322/2021)	Final	Administrative, Pharmacovigilance, Safety, Procedural
EU	EMA	Consideration on core requirements for RMPs of COVID19 vaccines (EMA/PRAC/73244/2022), version 3	Final	Pharmacovigilance, Safety, Vaccines
EU	EMA	IRIS guide for applicants (EMA/444925/2018), Version 2.6	Final	Procedural, Application Process, Inspections, Orphans, Rare Diseases
EU	EMA	Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation (EMA/41277/2007 Rev. 14)	Final	Procedural, Orphans, Rare Diseases, Application Process
EU	EMA	Guide to CTIS Training Catalogue - CTIS Training Programme (Version 1.1)	Final	Clinical Trials, Procedural
EU	EMA	New product information wording – Extracts from PRAC recommendations on signals Adopted at the 10-13 January 2022 PRAC (EMA/PRAC/13256/2022)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 Rev. 6)	Final	Product Information, Blood Products
EU	EMA	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.7)	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
EU	EMA	Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (EMA/61464/2022)	Final	Clinical Trials, Compliance, Inspections
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. 97) [Track Version]	Final	Procedural, Safety, Pharmacovigilance, Variations
EU	EMA	Roles and permissions matrix summary - Authority Workspace - CTIS Training Programme: Module 7 (Version 2.21)	Final	Clinical Trials, Procedural
EU	EMA	Member States Business Processes and Roles - Use of Member States Preparedness - CTIS Training Programme: Module 7 (Version 1.67)	Final	Clinical Trials, Procedural
EU	EMA	Roles and permissions matrix summary - Sponsors Workspace - CTIS Training Programme: Module 7 (Version 2.27)	Final	Clinical Trials, Procedural
EU	EMA	Sponsors Business Processes and Roles - Use of Sponsors Preparedness - CTIS Training Programme: Module 7 (Version 1.43)	Final	Clinical Trials, Procedural
EU	EMA	Notices and alerts per role - CTIS Training Programme: Module 07	Final	Clinical Trials, Procedural
EU	EMA	Guide on access to unpublished documents (EMA/304162/2014 Rev.5)	Final	Administrative, Procedural
EU	EMA	Digital Application Dataset Integration (DADI) electronic application form project: Q&A (EMA/451086/2021)	Final	Administrative, Procedural, Application Process
Hong Kong	DoH	Guidance Notes on Registration of Pharmaceutical Products/Substances	Final	Application Process
Hong Kong	DoH	Launch of Electronic Clinical Trial System (e-CTS)	Final	Clinical Trials, Procedural
Hong Kong	DoH	Alternative Inspection Approaches	Final	Inspections, Compliance, Procedural
Hong Kong	DoH	Letter to industry - Requirements of Elemental Impurities Levels/Limits in Registered Pharmaceutical Products	Final	Safety
Hong Kong	DoH	Requirement of Elemental Impurities Levels/Limits in Registered Pharmaceutical Products	Final	Safety
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Probenecid	Final	Prescribing, Labeling
Ireland	HPRA	Guide to Labels and Leaflets of Human Medicines (AUT-G0034-23) [Track Version]	Final	Labeling, Product Information
Ireland	HPRA	Application for Licence for Category 1 Scheduled Substances (Precursor Chemicals)	Final	Procedural
Ireland	HPRA	Application for Registration of Category 2 Scheduled Substances (Precursor Chemicals)	Final	Procedural
Ireland	HPRA	Application for Registration of Category 3 Scheduled Substances (Precursor Chemicals)	Final	Procedural
Ireland	HPRA	Application for Export Authorisation for Scheduled Substances	Final	Procedural, Trade
Lithuania	SMCA Lithuania	Regarding medicinal products for which “sunset clause” may already be applied	Final	Procedural
Lithuania	SMCA Lithuania	Requests for Lithuania acting as Reference Member State	Final	Application Process, Procedural
Malaysia	NPRA	Guide on how to upload the BE study report and other relevant documents in Quest 3+ system under Section P9	Final	Clinical Trials, Procedural
Pakistan	DRAP	The Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022	Draft	Compliance, Inspections
Pakistan	DRAP	PIRIMS software: Manufacturers of Pharmaceuticals and Biologicals Drug	Final	Application Process, Procedural, Administrative
Pakistan	DRAP	Adverse Event Reporting Guidelines for Patients	Draft	Pharmacovigilance, Safety
Pakistan	DRAP	Adverse Event Reporting Guidelines for Healthcare Professionals	Draft	Pharmacovigilance, Safety
Pakistan	DRAP	Imports & Exports of Therapeutic Goods (QALT/GL/IP/004), 1^st Edition	Draft	Trade, Supply, Procedural
Philippines	FDA Philippines	Guidelines on the Issuance of License to Operate for Drug Establishments Engaged in E-Pharmacy	Draft	Trade, Supply, Distribution
Saudi Arabia	Saudi FDA	Guidance for Priority Review of Product Registration (Version 5.1)	Final	Application Process
South Africa	SAHPRA	BAU Variations Communication (Version 3)	Final	Variations
South Africa	SAHPRA	Request for Priority Review of New Medicines and Variations Applications (Version 1)	Final	Application Process, 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	RMP ICH E2E information submission – HMP (Version 4)	Final	Pharmacovigilance, Safety
Switzerland	Swissmedic	Validity of GMP certificates during the COVID-19 pandemic	Final	Manufacturing, GMP, Quality, Procedural
Tanzania	TMDA	TMDA’s online submission system of query responses	Final	Administrative, Procedural
Uganda	NDA	The National Drug Policy and Authority (Fees) Regulations, 2022	Final	Application Process, Procedural
UK	HRA	Model Non-Interventional Study Agreement (mNISA) – IRAS	Final	Clinical Trials, Procedural
UK	HRA	Clinical Research Organisation model Non-Interventional Study Agreement (CRO-mNISA) - IRAS	Final	Clinical Trials, Procedural
UK	HRA	Model Confidentiality Disclosure Agreements (mCDA) Template Agreement - IRAS	Final	Clinical Trials, Procedural
UK	HRA	Guidance - A model Confidentiality Disclosure Agreement (mCDA) template, for use during the early set-up of commercial contract research in NHS organisations	Final	Clinical Trials, Procedural
UK	MHRA	The Target Development Profile Toolkit	Final	Application Process, Procedural
UK	MHRA	Clinical trials applications for Coronavirus (COVID-19)	Final	Clinical Trials
UK	MHRA	Clinical trials for medicines: manage your authorisation, report safety issues	Final	Clinical Trials
UK	MHRA	Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland	Final	Trade, Quality, Procedural, Manufacturing, GMP
US	FDA	Pre-Launch Activities Importation Requests (PLAIR): Guidance for Industry	Final	Procedural, Trade, Supply
US	FDA	Inclusion of Older Adults in Cancer Clinical Trials - Guidance for Industry	Final	Clinical Trials, Oncology
US	FDA	Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics - Guidance for Industry	Final	Clinical Trials, Oncology
US	FDA	Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics - Guidance for Industry	Final	Clinical Trials, Oncology, Procedural
US	FDA	Development of Non-Opioid Analgesics for Acute Pain - Draft Guidance for Industry	Draft	Clinical, Medical
US	FDA	COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels - Guidance for Industry and Investigators	Final	Safety, Product Development
US	FDA	Clinical Pharmacology Considerations for Antibody-Drug Conjugates - Guidance for Industry	Draft	Clinical Pharmacology
US	FDA	Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic - Guidance for Industry	Final	Pharmacology, Toxicology
US	FDA	Patient-Focused Drug Development: Methods to Identify What Is Important to Patients - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders	Final	Product Development, Procedural
US	FDA	Draft Guidance on Aclidinium Bromide; Formoterol Fumarate - Powder, Metered (Inhalation)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Apomorphine Hydrochloride – Film (Sublingual)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Atropine Sulfate - Solution/Drops (Ophthalmic)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Capmatinib Hydrochloride – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Cladribine – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Dicyclomine Hydrochloride – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Dolutegravir Sodium - Tablet, For Suspension (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Enzalutamide – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Estradiol - Gel, Metered (Transdermal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Estradiol – Spray (Transdermal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Etelcalcetide – Solution (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Flortaucipir F-18 – Solution (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Fluoroestradiol F-18 – Solution (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Heparin Sodium – Injectable (Injection)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Irinotecan Hydrochloride - Injectable, Liposomal (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Leuprolide Acetate – Powder (Subcutaneous); Strength 30 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Leuprolide Acetate – Powder (Subcutaneous); Strength: 45 mg	Draft	Generics, Product Development
US	FDA	Draft Guidance on Mirabegron - For Suspension, Extended Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Nusinersen Sodium – Solution (Intrathecal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Posaconazole - For Suspension, Delayed Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Progesterone – System (Vaginal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Remdesivir – Powder (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Remdesivir – Solution (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ripretinib – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Selpercatinib – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Selumetinib Sulfate – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Sodium Chloride - Aerosol, Metered (Inhalation)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Vasopressin – Solution (Intravenous)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Viloxazine Hydrochloride - Capsule, Extended Release (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Apixaban – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clozapine – Suspension (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clozapine – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Clozapine - Tablet, Orally Disintegrating (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Enzalutamide – Capsule (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Estradiol – Gel (Transdermal)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Gefitinib – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Liothyronine Sodium – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Methylprednisolone Acetate – Injectable (Injection)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Mycophenolate Mofetil - For Suspension (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Osimertinib Mesylate – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Ruxolitinib Phosphate – Tablet (Oral)	Draft	Generics, Product Development
US	FDA	Draft Guidance on Valbenazine Tosylate – Capsule (Oral)	Draft	Generics, Product Development

Global Pharma Guidance Tracker – February 2022

More from Global Pharma Guidance Update

More from Regulatory Trackers