Country	Organization	Document	Status	Category
International	WHO	Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the COVID-19 outbreak	Final	Clinical Trials, Manufacturing, Compliance, Procedural
International	WHO	WHO Biowaiver Project- Preparation for Cycle IV (2021): Prioritization exercise of active pharmaceutical ingredients on the WHO Model List of Essential Medicines for solubility determination and Biopharmaceutics Classification System-based classification (QAS/20.850)	Draft	Procedural, Safety, Efficacy, Clinical Trials, Generics
International	WHO	Good manufacturing practices: water for pharmaceutical use (QAS/20.842/Rev.1)	Draft	Quality, Safety, Manufacturing
International	WHO	Dissolution Test for Solid Oral Dosage Forms: Draft proposal for revision in The International Pharmacopoeia (QAS/20.837)	Draft	Quality, Safety, Efficacy
International	WHO	Evaluating and publicly designating regulatory authorities as WHO listed authorities (QAS/19.828/Rev.1)	Draft	Procedural, Inspections
International	WHO	Recommendations to assure the quality, safety and efficacy of typhoid conjugate vaccines: Replacement of Annex 3 of WHO Technical Report Series, No. 987 (WHO/BS/2020.2387)	Draft	Vaccines, Quality, Safety, Efficacy
International	WHO	Guidelines for the safe production and quality control of poliomyelitis vaccines: Amendment to Annex 4 of WHO Technical Report Series, No. 1016 (WHO/BS/2020.2381)	Draft	Vaccines, Quality, Safety, Efficacy
International	ICH	M7 Q&A Support Document	Draft	Safety
International	IPRP	Identification of Medicinal Products (IDMP): Frequently Asked Questions	Final	Application Process, Safety, Procedural, Product Information, Pharmacovigilance
Australia	TGA	Form - Submission of an updated RMP	Final	Procedural, Pharmacovigilance, Safety
Belgium	FAMHP	Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms	Final	Clinical Trials
Canada	HC	Changes to notification requirements for biologic drugs: Notice to industry	Final	Clinical Trials, Distribution, Procedural, Compliance
Canada	HC	Notice – Release of ICH E9(R1): Defining the Appropriate Estimand for a Clinical Trial/ Sensitivity Analyses (20-109237-45)	Final	Clinical Trials, Efficacy
Czech Republic	SÚKL	Questions and Answers on the Use of Advanced Therapy Medicinal Products with Out-of-Specification Release Test Results	Final	Cellular and Gene Therapy, Advanced Therapies, Safety, Manufacturing
Denmark	DMA	Exchange of adverse reaction reports - Q and A	Final	Safety, Pharmacovigilance
EU	EC	Clinical Trials Regulation (EU) No 536/2014: Questions & Answers	Draft	Clinical Trials
EU	EDQM	Clarification on the acceptability of requests for revision of CEP applications	Final	Application Process, Procedural, Quality, Safety, Efficacy
EU	CMDh	Decentralised, Mutual Recognition, Repeat Use Procedure: RMS Assessment Report on Similarity (CMDh/422/2020 Rev.0)	Final	Generics, Procedural
EU	CMDh	Decentralised Procedure: RMS Day 70 Preliminary Assessment report – Overview and List of Questions (CMDh/200/2007 Rev.9)	Final	Generics, Procedural
EU	CMDh	Decentralised Procedure: RMS Day 120 Draft Assessment Report – Overview (CMDh/208/2005 Rev.9)	Final	Generics, Procedural
EU	CMDh	Recommendations on common regulatory approaches for allergen products (CMDh/399/2019, Rev.0)	Final	Clinical, Medical
EU	CMDh	Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/ Recommendation papers (CMDh/197/2010, Rev.7) [Track version]	Final	Variations, Application Process, Procedural
EU	CMDh	Q&A – QP Declaration (CMDh/340/2015/Rev.6) [Track version]	Final	Manufacturing, Procedural
EU	CMDh	Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications (CMDh/259/2012, Rev. 2) [Track version]	Final	Application Process, Procedural
EU	CMDh	Cover letter for Variation Applications in the Mutual Recognition Procedure	Final	Variations, Procedural
EU	CMDh	Template for cover letter for new applications submitted through MRP/DCP (CMDh/226/2007 Rev.8)	Final	Application Process, Procedural
EU	CMDh	Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures (CMDh/006/2008, Rev.22) [Track version]	Final	Variations, Application Process, Procedural
EU	CMDh	Notification for product information amendment under Article 61(3) (Not accompanying a variation change)	Final	Product Information, Procedural
EU	CMDh	CMDh Best Practice Guide on Multilingual Packaging (CMDh/413/2019/Rev.2) [Track version]	Final	Labeling, Packaging, Distribution
EU	CMDh	Template to notify the implementation of a COVID-19-related Emergency Change Management Process (ECMP)	Final	Variations, Compliance
EU	CMDh	CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures (CMDh/004/2005/Rev.17) [Track version]	Final	Application process, Procedural
EU	CMDh	Core SmPC for hormone replacement therapy products (CMDh/131/2003 Rev. 7) [Track version]	Final	Product Information, Labeling, Packaging
EU	CMDh	Core package leaflet for hormonal replacement therapy products based on core SmPC HRT revision 7, June 2020 (CMDh/240/2011, Rev.5)	Final	Product Information, Labeling, Packaging
EU	EMA	Guidance for ASMF holders and MA holders on Providing Regulatory Information in Electronic Format (Version 2.3)	Final	Application Process, Procedural
EU	EMA	User Guidance for submissions via eSubmission Gateway/Web Client using xml delivery files	Final	Application Process, Procedural
EU	EMA	EUnetHTA-EMA Parallel consultation: briefing document template	Final	Application Process, Procedural, Administrative
EU	EMA	New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC (EMA/PRAC/367622/2020)	Final	Labeling, Product Information, Safety, Pharmacovigilance
EU	EMA	List of signals discussed at PRAC since September 2012 (EMA/PRAC/530804/2013)	Final	Safety, Pharmacovigilance
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (EMA/630645/2012 Rev.94)	Final	Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev. 80)	Final	Pharmacovigilance, Safety
EU	EMA	Template letter of intent for request of scientific advice or protocol assistance	Final	Procedural, Application Process
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/383482/2020)	Final	Product Information, Procedural
EU	EMA	The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (EMA/95098/2010 Rev.8)	Final	Clinical Trials, Real World Data, Pharmacovigilance
EU	EMA	Q&A: Good clinical practice (GCP)	Final	Clinical Trials
EU	EMA	EudraVigilance registration manual (EMA/13454/2020, Rev. 8)	Final	Pharmacovigilance, Safety
EU	EMA	Guideline on the quality of water for pharmaceutical use (EMA/CHMP/CVMP/QWP/496873/2018)	Final	Safety, Quality
EU	EMA	Change of applicant checklist - pre-submission guidance (human) (17 July 2020 - Rev. 1)	Final	Application Process, Procedural, Administrative
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.24)	Final	Procedural, Compliance, Administrative
EU	EMA	Dates of 2020 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (EMA/444946/2017 Rev.2)	Final	Procedural, Application Process
Hong Kong	DoH	Pharmacy and Poisons (Amendment) Ordinance 2020 to Regulate Advanced Therapy Products	Final	Cellular and Gene Therapy, Advanced Therapies
Hong Kong	DoH	Invitation for Using the Pharmaceuticals Licence Application and Movement Monitoring System	Final	Trade, Application Process, Procedural
India	CDSCO	Circular regarding Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed	Final	Trade, Supply
India	CDSCO	Regarding validity of existing Registration Certificates for import of drugs	Final	Trade, Supply
India	CDSCO	Exemption of hand sanitizer from sale licence	Final	Procedural, Supply
India	CDSCO	Procedure to be followed for subsequent applicant in respect of FDCs relating to Vitamins, Minerals, Micronutrients, etc. declared as rational by Prof. Kokate Committee and approved by DCG(I)	Final	Procedural, Application Process
Ireland	HPRA	Guide to Labels and Leaflets of Human Medicines (AUT-G0034-21) [Track version]	Final	Labeling, Packaging
Ireland	HPRA	Application for a Change to Labels and/or Patient Information Leaflets not connected with changes to the SmPC	Final	Product Information, Labeling, Packaging
Lithuania	SMCA	Information for Applicants on the Zero-Day Procedure	Final	Application Process, Procedural
Malaysia	NPRA	Application Form/checklist - Evaluation on the Need for Bioequivalence (BE) Study Inspection (BEEC/F-017)	Final	Inspection, Generics, Clinical Trials
Malaysia	NPRA	Application Form/checklist - Information for Evaluation on the Need for BE Study Inspection (BEEC/F-017-L1)	Final	Inspection, Generics, Clinical Trials
Malaysia	NPRA	Inspection Application for NPRA Bioequivalence Centre Compliance Programme (Foreign) (BEEC/F-004)	Final	Inspection, Generics, Clinical Trials
Malaysia	NPRA	Inspection Application for NPRA Bioequivalence Centre Compliance Programme (Local) (BEEC/F-003)	Final	Inspection, Generics, Clinical Trials
Malaysia	NPRA	Assessment Application Determination Manual: Determination of BE Study Examination Requirements (BEEC/F-018) (In Malay)	Final	Inspection, Generics, Clinical Trials
New Zealand	Medsafe	Reclassification of codeine	Final	Product Classification, Labeling, Compliance
Philippines	FDA Philippines	Administrative Order on "Adoption of the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) - Prequalified Drug Products and Vaccines”	Draft	Application Process, Procedural
Philippines	FDA Philippines	Implementing Rules and Regulations on Revised Application Process and Requirements for Post-Approval Changes of Pharmaceutical Products, and Institutionalization of the Philippine Variation Guidelines	Draft	Variations
Philippines	FDA Philippines	Guidelines for the Use of the FDA eServices Portal System for License to Operate (LTO) Applications Pursuant to Administrative Order (AO) No. 2020-0017	Draft	Application Process, Procedural
Philippines	FDA Philippines	Amendment to FDA Circular No. 2020-012 entitled Guidelines for the Registration of Drug Products under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19)	Final	Application Process, Procedural
Philippines	FDA Philippines	Interim Guidelines Governing the Issuance of a Permit to Register to Drug Importers for Foreign Drug Manufacturers	Final	Compliance, Inspection, Trade, Procedural
Saudi Arabia	SFDA	Data Requirements for Radiopharmaceuticals	Draft	Application Process, Product Development
Singapore	HSA	Guidance on the conduct of clinical trials in relation to the COVID-19 situation (Updated 29 July 2020)	Final	Clinical Trials
South Africa	SAHPRA	Guidance on Good Practice (GxP) inspections during emergencies/disasters including the COVID- 19 pandemic	Final	Compliance, Inspections
South Africa	SAHPRA	Checklist for remote virtual GDP inspection	Final	Compliance, Inspections, Distribution
South Africa	SAHPRA	Checklist for remote virtual GCP inspection	Final	Compliance, Inspections, Clinical Trials
South Africa	SAHPRA	Guideline for the API Master File (APIMF) procedure	Final	Quality, Safety, Application Process, Procedural
South Africa	SAHPRA	Two-Weekly Abridged COVID-19 Interim Progress Report Form For Clinical Trials	Final	Clinical Trials, Procedural
Switzerland	Swissmedic	Description of document protection HMV4	Final	Intellectual Property, Application Process, Procedural
Switzerland	Swissmedic	Authorisation of human medicinal product with known active pharmaceutical substance HMV4	Final	Generics, Clinical Trials, Application Process
Switzerland	Swissmedic	Changeover to electronic submission of notifications of major changes from autumn 2020	Final	Procedural, Variations
Tanzania	TMDA	Notice on withdrawal of dormant applications for registration of medicinal products	Final	Procedural, Application Process
Uganda	NDA	Pharmacovigilance guidelines for licensed persons, pharmaceutical companies, and market authorization holders	Final	Pharmacovigilance, Safety
UK	MHRA	Good clinical practice for clinical trials	Final	Procedural, Clinical Trials
UK	MHRA	Medicines: apply for a variation to your marketing authorisation	Final	Variations
UK	MHRA	MHRA regulatory flexibilities resulting from coronavirus (COVID-19)	Final	Compliance, Procedural
UK	MHRA	Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak	Final	Manufacturing, GMP, Quality, Safety, Procedural
US	FDA	Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans	Final	Procedural, Clinical Trials, Pediatrics
US	FDA	Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval: Guidance for Industry	Final	Clinical, Medical, Oncology
US	FDA	Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry	Draft	Labeling
US	FDA	Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry	Final	Pharmaceutical Quality, Manufacturing, GMP
US	FDA	Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry: Draft Guidance for Industry	Draft	Chemistry, Manufacturing and Controls, Oncology
US	FDA	Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research: Draft Guidance for Industry	Draft	Pharmaceutical Quality, Chemistry, Manufacturing and Controls
US	FDA	Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections: Guidance for Industry	Final	Clinical, Medical, Clinical Trials, Oncology
US	FDA	Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies: Guidance for Industry	Final	Clinical, Medical, Clinical Trials, Oncology
US	FDA	Cancer Clinical Trial Eligibility Criteria: Brain Metastases: Guidance for Industry	Final	Clinical, Medical, Clinical Trials, Oncology
US	FDA	Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients: Guidance for Industry and IRBs	Final	Clinical, Medical, Clinical Trials, Oncology, Pediatrics
US	FDA	Compliance Policy Guide CPG Sec. 280.110: Microbiological Control Requirements - Licensed AntiHuman Globulin & Blood Grouping Reagents: Guidance for FDA Staff	Final	Investigation and Enforcement, Compliance, Inspection
US	FDA	Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration	Final	Combination Products, Digital Health
US	FDA	Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: Guidance for Industry and Food and Drug Administration Staff	Final	Cellular and Gene Therapy, Advanced Therapies

Global Pharma Guidance Tracker – July 2020

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