Country	Organization	Document	Status	Category
International	WHO	WHO guidelines on the transfer of technology in pharmaceutical manufacturing (QAS/20.869)	Draft	Manufacturing, GMP
International	ICH	eCTD v4 IWG Question and Answer and Specification Change Request Document (Version 1.4)	Final	Procedural, Application Process
International	ICH	ICH Reflection paper - Proposed ICH Guideline Work to Advance Patient Focused Drug Development	Draft	Product Development
Australia	TGA	Introduction to the Poisons Standard (Version 1.0)	Final	Safety, Compliance
Australia	TGA	Introduction to the Permissible Ingredients Determination (Version 1.0)	Final	Safety, Compliance
Australia	TGA	Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements	Draft	Manufacturing, GMP, Labeling, Packaging
Australia	TGA	Advertising therapeutic goods that are only sold to health professionals	Final	Advertising, Promotion
Australia	TGA	Listed medicines that are required to be tested for the presence of Aristolochic acids	Final	Safety, Compliance, Quality, GMP
Belgium	FAMHP	Coronavirus: new online form to report suspected adverse reactions to a COVID-19 vaccine	Final	Safety, Pharmacovigilance, Vaccines
Belgium	FAMHP	Voluntary Joint pilot project between FAMHP, the College, accredited Ethics Committees and sponsors for processing of applications for the authorisation of clinical trials and substantial modifications on medicinal products for human use in accordance with the spirit of the Regulation (EU) No 536/2014 and of the law on Clinical Trial Regulation (CTR) (Version 9.0)	Final	Clinical Trials
Belgium	FAMHP	CTR pilot project VHP plus process: Addendum to the CTR pilot project guidance for participating parties (Version 2.0)	Final	Clinical Trials
Belgium	FAMHP	Risk Minimisation Activities (RMA): clarifications for authorisation holders on Circular No. 635	Final	Pharmacovigilance, Safety
Canada	HC	Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders	Draft	Clinical Trials, Procedural
Canada	HC	Validation rules for regulatory transactions provided to Health Canada in the electronic Common Technical Document (eCTD) format	Final	Procedural, Application Process
Canada	HC	Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format	Final	Procedural, Application Process
Canada	HC	Validation Rules for Transactions Containing the Regulatory Enrolment Process (REP) Company XML File	Final	Procedural, Application Process
Canada	HC	Consultation on ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient-Focused Drug Development	Draft	Product Development
Canada	HC	Guidance Document - Certificates of Supplementary Protection	Final	Intellectual Property, Procedural
Canada	HC	Notice to stakeholders: Harmonizing fludeoxyglucose (F-18 FDG) product monographs	Final	Labeling, Product Information, Safety
Czech Republic	SÚKL	Opinion of SÚKL's Department of Clinical Trials on Medicinal Products on Ongoing Clinical Trials and To-Be-Commenced Clinical Trials in Light of the COVID-19 Epidemiological Situation of 22 December 2020 [Track version]	Final	Clinical Trials
Denmark	DMA	Fees for clinical trials	Final	Clinical Trials, Procedural
Denmark	DMA	Fees payable for medicinal products and companies - Fees applicable from 1 January 2020 to 31 December 2021 (in Danish)	Final	Administrative, Procedural
Denmark	DMA	Clinical Trials - IE/NI Protocol & Brexit	Final	Clinical Trials, Procedural, Compliance
Denmark	DMA	Exchange of adverse reaction reports - Q and A	Final	Safety, Pharmacovigilance
EU	EC	Commission Notice - Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period	Final	Procedural, Supply, Trade, Compliance
EU	EDQM	Brexit: End of Mutual Recognition with the UK - Information on use of EU OCABR certificates issued by the UK before 01/01/2021 for vaccines for human use and human blood derived medicinal products	Final	Quality, Safety, Efficacy, Procedural, Vaccines
EU	EDQM	New policy for dissolution and disintegration testing in Ph. Eur. monographs	Final	Quality, Safety, Efficacy
EU	CMDh	CMDh annotated QRD template for MR/DC procedures (CMDh/201/2005, Rev.11) [Track version]	Final	Procedural, Product Information, Labeling
EU	CMDh	Requirements on Submissions (number and format) for New Marketing Authorisation Applications within MRP, DCP and National Procedures (CMDh/085/2008, Rev.24) [Track version]	Final	Procedural, Application Process
EU	CMDh	Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures (CMDh/006/2008, Rev.24) [Track version]	Final	Procedural, Variations
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (CMDh/330/2015, Rev.28)	Final	Pharmacovigilance, Safety
EU	CMDh	CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (CMDh/412/2019, Rev.8) [Track version]	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
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. 25) [Track version]	Final	Variations, Procedural
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.24) [Track version]	Final	Variations, Procedural
EU	CMDh	Chapter 6 - CMDh Best Practice Guide for the processing of grouped applications in the Mutual Recognition Procedure (CMDh/296/2013 Rev.23) [Track version]	Final	Procedural, Variations
EU	CMDh	Mock-ups, specimens and samples – Variation (CMDh/261/2012, Rev.4) [Track version]	Final	Procedural, Variations, Labeling, Packaging
EU	CMDh	Q&A - Pharmacovigilance Legislation Regulation (EU) No 1235/2010 and Directive 2010/84/EU (CMDh/257/2012, Rev.23) [Track version]	Final	Safety, Pharmacovigilance
EU	CMDh	Template – Mutual recognition procedure: Preliminary Renewal Assessment Report (CMDh/191/2009 Rev.5)	Final	Procedural, Administrative
EU	CMDh	Template – Reference Member State: End of Renewal Procedure (CMDh/219/2008/Rev.6)	Final	Procedural, Administrative
EU	CMDh	“Blue – Box” requirements (CMDh/258/2012/Rev.22) [Track version]	Final	Labeling, Product Information
EU	CMDh	Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications (CMDh/259/2012, Rev. 3) [Track version]	Final	Procedural, Application Process, Variations
EU	CMDh	Mock-ups, specimens and samples – New application (CMDh/260/2012, Rev.7) [Track version]	Final	Procedural, Application Process, Labeling, Packaging
EU	CMDh	Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (CMDh/373/2018, Rev.5 Corr.1) [Track version]	Final	Procedural, Compliance
EU	CMDh	Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP (CMDh/426/2020)	Final	Procedural, Application Process, Administrative
EU	EMA	New product information wording – Extracts from PRAC recommendations on signals Adopted at the 23-26 November 2020 PRAC (EMA/PRAC/630092/2020)	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	Dossier requirements for centrally authorised products (CAPs) (EMA/497021/2012 Rev. 26)	Final	Application Process, Procedural
EU	EMA	Dossier requirements for NAPs (referral, PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (EMA/13015/2014 Rev. 9)	Final	Application Process, Procedural, Combination Products, Safety, Pharmacovigilance
EU	EMA	Pharmacovigilance Fees Questions & Answers (Q&As) (EMA/175299/2015 Rev.5)	Final	Procedural, Safety, Pharmacovigilance
EU	EMA	Questions and answers to Stakeholders on the implementation of the Protocol on Ireland/Northern Ireland (EMA/520875/2020)	Final	Procedural
EU	EMA	Compliance with QRD template v10.2	Final	Procedural, Product Information, Labeling
EU	EMA	QRD product-information annotated template (Version 10.2, 01/2021) [Track version]	Final	Procedural, Product Information, Labeling
EU	EMA	QRD Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products	Final	Procedural, Product Information, Labeling
EU	EMA	QRD Appendix V - Adverse-drug-reaction reporting details (EMA/67830/2013, Version 21)	Final	Procedural, Product Information, Labeling, Safety, Pharmacovigilance
EU	EMA	Questions and answers on labelling flexibilities for COVID-19 vaccines (EMA/689080/2020 rev.1)	Final	Labeling, Product Information, Vaccines
EU	EMA	Member states contact points for review of national versions of the content of mobile scanning and other technologies - Review of ‘additional’ information as per Article 62 of Directive 2001/83/EC (EMA/358267/2015 rev. 6)	Final	Procedural, Product Information
EU	EMA	List of official languages per country (EMA/315185/2010 rev. 3)	Final	Procedural, Product Information, Labeling
EU	EMA	Acceptability of IU as abbreviation for International Units in the strength of human medicinal products (EMA/704692/2012 rev.1)	Final	Procedural, Product Information, Labeling
EU	EMA	Abbreviation of names of days on calendarised blisters (EMA/188814/2012 rev.1)	Final	Procedural, Product Information, Labeling
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 1)	Final	Labeling, Packaging, Procedural
EU	EMA	Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages (EMA/670900/2020 Rev 7)	Final	Procedural, Product Information, Labeling
EU	EMA	Template or form: Pre-submission request form - PRIME	Final	Procedural, Application Process
EU	EMA	Template or form: Application form for European Medicines Agency certificates of medicinal products	Final	Procedural, Manufacturing, Trade
EU	EMA	Template or form: Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)	Final	Procedural
EU	EMA	Timetable: Initial (full) marketing authorisation application (EMA/119185/2015 Rev.8)	Final	Procedural, Administrative
EU	EMA	Timetable: Extension application (EMA/412809/2015 Rev.5)	Final	Procedural, Administrative
EU	EMA	Timetable: Extension application – ATMP (EMA/824995/2015 Rev.4)	Final	Procedural, Administrative, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	Template or form: Orphan designation sponsor’s name and/or address change notification letter	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Procedural advice for post-orphan medicinal product designation activities (EMA/469917/2018 Rev. 10)	Final	Procedural, Orphans, Rare Disease
EU	EMA	Template or form: Dossier administrative validation checklist for initial marketing authorisation applications by applicants (EMA/573531/2018 - Rev. 3)	Final	Procedural, Application Process
EU	EMA	Timetable: Initial (Full) marketing authorisation application - ATMP (EMA/824993/2015 Rev.4)	Final	Procedural, Administrative, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	Timetable initial (full) marketing authorisation application - Accelerated assessment (EMA/339594/2016 Rev.5)	Final	Procedural, Administrative
EU	EMA	Timetable: Informed consent and multiple application (EMA/488671/2015 Rev.4)	Final	Procedural, Administrative
EU	EMA	Timetable: Accelerated assessment request for initial marketing authorisation applications (EMA/347524/2016 Rev.2)	Final	Procedural, Administrative
EU	EMA	Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance (EMA/CHMP/472383/2020)	Draft	Generics, Product Development
EU	EMA	Template or form: ATMP classification - administrative information sheet	Final	Procedural, Product Classification, Cellular and Gene Therapy, Advanced Therapies
EU	EMA	Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CAT/GTWP/671639/2008 Rev. 1)	Final	Quality, Safety, Efficacy, Cellular and Gene Therapy, Advanced Therapies, Manufacturing
EU	EMA	IRIS guide for applicants (how to create and submit scientific applications, for industry and individual applicants) Version 1.9 (EMA/444925/2018)	Final	Procedural, Application Process, Orphans, Rare Diseases
EU	EMA	COMP members interaction with sponsors of orphan designation applications (EMA/COMP/150409/2006 Rev.1)	Final	Procedural, Orphans, Rare Diseases
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (EMA/630645/2012 Rev.98)	Final	Safety, Pharmacovigilance
EU	EMA	Procedural advice on appeal procedure for orphan medicinal product designation or review of orphan designation criteria at the time of marketing authorisation (EMA/2677/01 Rev.3)	Final	Procedural, Orphans, Rare Diseases
EU	EMA	Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance (EMA/CHMP/176098/2020)	Final	Generics, Product Development
EU	EMA	Guidance on good manufacturing practice and good distribution practice: Questions and answers	Final	GMP, Manufacturing, Quality
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/688529/2020)	Final	Product Information, Procedural
EU	EMA	Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation (EMA/41277/2007 Rev. 131)	Final	Procedural, Orphans, Rare Disease
EU	EMA	ICH reflection paper on proposed ICH guideline work to advance patient focused drug Development (EMA/CHMP/ICH/415588/2020)	Draft	Product Development
EU	EMA	Article 57 product data (EMA/518502/2018, Rev.29)	Final	Procedural, Compliance, Administrative
EU	EMA	PSUR Repository - release notes (EMA/507909/2016)	Final	Safety, Pharmacovigilance
Finland	Fimea	Piloting of the EU Regulation on Clinical Trials in Finland	Final	Clinical Trials
Hong Kong	DoH	Phase Out of Manual Application Submission for Import and Export Licenses/Certificates for Pharmaceutical Products and Dangerous Drugs	Final	Procedural, Application Process, Trade, Supply
Hong Kong	DoH	Import and Re-Export of unregistered COVID-19 Vaccines	Final	Procedural, Trade, Vaccines
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Codergocrine mesilate	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Metronidazole	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Diprophylline	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Azelaic acid	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Strengthening the Sales Control of Pharmaceutical Products containing Trospium chloride	Final	Labeling, Compliance, Prescribing
Hong Kong	DoH	Enhancement of Regulatory Control of Skin Antiseptic Products	Final	Product Classification, Compliance
Iceland	IMA	Upcoming changes to Icelandic translations of Product Information	Final	Product Information, Labeling
India	CDSCO	Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed	Final	Trade, Supply
India	CDSCO	Clarification regarding reference standards	Final	Procedural, Supply, Labeling
Ireland	HPRA	Guide to Renewal of Marketing Authorisations – Human Medicines (AUT-G0025-6) [Track version]	Final	Application Process, Procedural
Ireland	HPRA	COVID-19 Vaccine Adverse Reaction Report Form	Final	Safety, Pharmacovigilance, Vaccines
Ireland	HPRA	Form - Batch-Specific Requests for Human Medicines	Final	Quality, GMP, Manufacturing, Supply
Ireland	HPRA	Guide to the Notification System for Exempt Medicinal Products (AUT-G0090-5) [Track version]	Final	Compliance, Compassionate Use
Malaysia	NPRA	Guidelines on Conditional Registration for New Chemical Entities and Biologics (2nd Edition)	Final	Application Process, Procedural, Vaccines
Pakistan	DRAP	Draft National Biosafety Guidelines for Research, Development, and Production of Human Stem Cells	Draft	Cellular and Gene Therapy, Advanced Therapies
Saudi Arabia	Saudi FDA	Adoption of ICH Guideline on Good Clinical Practice (GCP) E6(R2) (Version 3.0)	Final	Clinical Trials
Saudi Arabia	Saudi FDA	The GCC Guidance for Presenting the Labeling Information, SPC and PIL (Version 3.0)	Final	Product Information, Labeling
Saudi Arabia	Saudi FDA	Templates for Labeling information, SPC and PIL (Version 1.0)	Final	Product Information, Labeling
Saudi Arabia	Saudi FDA	Guidelines for Variation Requirements (Version 6.1)	Final	Variations
Singapore	HSA	Guidance on therapeutic product registration in Singapore (TPB-GN-005-006)	Final	Application Process, Procedural
Singapore	HSA	Application checklist for New Drug Application (NDA) and Generic Drug Application (GDA) (ICH CTD)	Final	Application Process, Generics, Procedural
Singapore	HSA	Application checklist for Major Variation (MAV) (ICH CTD)	Final	Application Process, Variations, Procedural
Singapore	HSA	Application checklist for New Drug Application (NDA) and Generic Drug Application (GDA) (Asean CTD-ACTD)	Final	Application Process, Procedural
Singapore	HSA	Application checklist for Major Variation (MAV) (Asean CTD-ACTD)	Final	Application Process, Variations, Procedural
Singapore	HSA	Guideline on PRISM Submission	Final	Application Process, Procedural
South Africa	SAHPRA	Post Importation Testing Guideline	Draft	Trade, Supply, Safety
South Africa	SAHPRA	Extension of Post Importation Testing Exemptions	Final	Trade, Supply, Safety
South Africa	SAHPRA	Lot Release Guideline for COVID-19 Vaccines	Final	Safety, Vaccines
Switzerland	Swissmedic	Out-of-Stock – COVID-19 – Authorisations for the temporary import and distribution of human medicines – Update	Final	Trade, Supply, Distribution
Switzerland	Swissmedic	Information about electronic pharmacovigilance reports	Final	Pharmacovigilance, Safety
Switzerland	Swissmedic	Joint Guidance of Swissmedic and Swissethics on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic (Version 2.4)	Final	Clinical Trials
Switzerland	Swissmedic	Optimising authorisation-related meetings with applicants	Final	Application Process, Procedural
Switzerland	Swissmedic	Guidance document: Meetings for applicants held with the Authorisation sector	Final	Application Process, Procedural
Switzerland	Swissmedic	Form – Company Meeting	Final	Application Process, Procedural
Switzerland	Swissmedic	Notice - Accelerated Application Hearing replaces existing application procedure for an FTP/temporary authorisation of human medicinal products	Final	Application Process, Procedural
Switzerland	Swissmedic	Guidance document: Fast-track authorisation procedure	Final	Application Process, Procedural
Switzerland	Swissmedic	Guidance document: Temporary authorisation for human medicinal products	Final	Application Process, Procedural
Switzerland	Swissmedic	Template – Decision minutes of Accelerated Application Hearing	Final	Application Process, Procedural
Switzerland	Swissmedic	New reporting routes for adverse drug reaction reports by healthcare professionals from 1 January 2021	Final	Safety, Pharmacovigilance
Uganda	NDA	Pharmacovigilance guidelines for licensed persons	Final	Safety, Pharmacovigilance
UK	MHRA	Guidance on responding to a GMP/GDP post inspection letter	Final	Compliance, Manufacturing, GMP, Distribution
UK	MHRA	Valproate use by women and girls	Final	Safety, Pharmacovigilance
UK	MHRA	Borderline products: how to tell if your product is a medicine	Final	Product Classification
UK	MHRA	Guidance on pharmacovigilance procedures	Final	Safety, Pharmacovigilance, Procedural
UK	MHRA	Send and receive information on adverse drug reactions (ADRs)	Final	Safety, Pharmacovigilance, Procedural
UK	MHRA	Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes	Final	Procedural, Application Process, Variations
UK	MHRA	Guidance for retailers: supplying over-the-counter medicines to Northern Ireland	Final	Procedural, Over-The-Counter Drugs, Supply, Trade
UK	MHRA	Medicines: register as a broker	Final	Procedural, Trade, Supply
UK	MHRA	Decentralised and mutual recognition reliance procedure for marketing authorisations	Final	Procedural, Application Process
UK	MHRA	European Commission (EC) Decision Reliance Procedure	Final	Procedural, Application Process
UK	MHRA	Unfettered Access Procedure for marketing authorisations approved in Northern Ireland	Final	Procedural, Application Process
UK	MHRA	Medicines: apply for a variation to your marketing authorisation	Final	Variations
UK	MHRA	Clinical trials for medicines: manage your authorisation, report safety issues	Final	Clinical Trials
UK	MHRA	Clinical trials for medicines: apply for authorisation in the UK	Final	Clinical Trials
UK	MHRA	Apply for a licence to market a medicine in the UK	Final	Procedural, Application Process
UK	MHRA	The Yellow Card scheme: guidance for healthcare professionals, patients and the public	Final	Safety, Pharmacovigilance
UK	MHRA	Guidance on submitting clinical trial safety reports	Final	Clinical Trials, Safety
UK	MHRA	Guidance on licensing biosimilars, ATMPs and PMFs	Final	Application Process, Biosimilars, Cellular and Gene Therapy, Advanced Therapies
UK	MHRA	Sourcing medicines for the Great Britain market from an approved country for import or Northern Ireland	Final	Trade, Supply, Distribution
UK	MHRA	Acting as a Responsible Person (import)	Final	Procedural, Trade, Manufacturing, GMP
UK	MHRA	List of approved countries for authorised human medicines - Approved countries for batch testing and importation of medicines	Final	Trade, Quality, Procedural, Manufacturing, GMP
UK	MHRA	Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)	Final	Procedural, Safety, Pharmacovigilance
UK	MHRA	Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland	Final	Trade, Quality, Procedural, Manufacturing, GMP
UK	MHRA	Importing investigational medicinal products into Great Britain from approved countries	Final	Clinical Trials, Quality, Manufacturing, GMP, Trade
UK	MHRA	Supplying investigational medicinal products to Northern Ireland	Final	Clinical Trials, Quality, Manufacturing, GMP, Trade
UK	MHRA	Supplying authorised medicines to Northern Ireland	Final	Trade, Procedural
UK	MHRA	Guidance on substantial amendments to a clinical trial	Final	Clinical Trials, Procedural
UK	MHRA	Guidance on the handling of applications for Centrally Authorised Products (CAPs)	Final	Procedural, Administrative
UK	MHRA	How Marketing Authorisation Applications referred under Article 29 are handled	Final	Procedural, Administrative
UK	MHRA	Orphan medicinal products in Great Britain	Final	Application Process, Procedural, Rare Disease, Orphans
UK	MHRA	Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice	Final	Application Process, Procedural
UK	MHRA	Reference Medicinal Products (RMPs)	Final	Generics
UK	MHRA	Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)	Final	Trade, Supply, Procedural, Distribution
UK	MHRA	Comparator products in Bioequivalence/Therapeutic Equivalence studies	Final	Generics, Clinical Trials
UK	MHRA	Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing	Final	Pharmacovigilance, Safety, Manufacturing, GMP, Quality
UK	MHRA	Periodic Safety Update Reports (PSURs) for medicinal products	Final	Safety, Pharmacovigilance
UK	MHRA	Implementing the Falsified Medicines Directive: Safety Features	Final	Packaging, Labeling, Safety
UK	MHRA	Borderlines between medical devices and medicinal products	Final	Product Classification
UK	MHRA	Register to make submissions to the MHRA	Final	Procedural, Administrative, Application Process
UK	MHRA	Guidance note on new assessment routes	Final	Application Process, Procedural
UK	MHRA	Handling of Active Substance Master Files and Certificates of Suitability	Final	Quality, Safety, Efficacy, Procedural
UK	MHRA	Submitting changes to labelling and patient information leaflets	Final	Labeling, Product Information, Variations
UK	MHRA	Apply to release a vaccine or a blood product to market	Final	Vaccines, Blood Products
UK	MHRA	Registration of clinical trials for investigational medicinal products and publication of summary results	Final	Clinical Trials, Procedural
UK	MHRA	Variations to Marketing Authorisations (MAs)	Final	Variations
UK	MHRA	Guidance on 150-day assessment for national applications for medicines	Final	Application Process, Procedural
UK	MHRA	Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending	Final	Procedural, Administrative
UK	MHRA	Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations	Final	Procedural, Administrative
UK	MHRA	Guidance on MAH and QPPV location	Final	Procedural, Safety, Pharmacovigilance
UK	MHRA	Format and content of applications for agreement or modification of a Paediatric Investigation Plan	Final	Clinical Trials, Pediatrics, Procedural
UK	MHRA	Renewing Marketing Authorisations for medicines	Final	Application Process, Procedural
UK	MHRA	Procedures for UK Paediatric Investigation Plan (PIPs)	Final	Clinical Trials, Pediatrics, Procedural
UK	MHRA	Registering new packaging information for medicines	Final	Packaging, Labeling, Product Information
UK	MHRA	Completed Paediatric Studies - submission, processing and assessment	Final	Clinical Trials, Pediatrics, Procedural
UK	MHRA	Webinars: information on how to make submissions to the MHRA	Final	Application Process, Procedural
UK	MHRA	Rolling review for marketing authorisation applications	Final	Application Process, Procedural
UK	MHRA	Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA	Final	Safety, Pharmacovigilance, Procedural
UK	MHRA	Medicines: get scientific advice from MHRA	Final	Application Process, Procedural, Product Development
UK	MHRA	Advertise your medicines	Final	Advertising, Promotion
UK	MHRA	Medicines: reclassify your product	Final	Switching, Product Classification
UK	MHRA	Best practice in the labelling and packaging of medicines	Final	Labeling, Packaging, Product Information
UK	MHRA	Medicines: packaging, labelling and patient information leaflets	Final	Labeling, Packaging, Product Information
UK	MHRA	Import a human medicine	Final	Trade, Supply, Distribution
UK	MHRA	Legal requirements for children's medicines	Final	Pediatrics, Clinical Trials
UK	MHRA	Blood: authorisations and safety reporting	Final	Blood Products
UK	MHRA	Medicines: register to manufacture, import or distribute active substances	Final	Application Process, Trade, Distribution, Supply
UK	MHRA	Best practice guidance on patient information leaflets	Final	Product Information, Safety
UK	MHRA	How to draft a direct healthcare professional communication	Final	Safety, Pharmacovigilance
UK	MHRA	MHRA fees: Fees payable to the MHRA for 2020 to 2021	Final	Administrative, Procedural
UK	MHRA	Blue Guide: advertising and promoting medicines	Final	Advertising, Promotion
UK	MHRA	EU guidance documents referred to in the Human Medicines Regulations 2012	Final	Procedural, Administrative
UK	MHRA	Good manufacturing practice and good distribution practice	Final	Manufacturing, GMP, Distribution, Supply, Compliance
UK	MHRA	Innovative Licensing and Access Pathway (ILAP) for medicines	Final	Application Process, Procedural
UK	MHRA	Medicines that you cannot export from the UK or hoard	Final	Trade, Supply, Distribution
UK	MHRA	Register for the Distance Selling logo	Final	Trade, Supply, Procedural
UK	MHRA	Good laboratory practice (GLP) for safety tests on chemicals	Final	Safety
UK	MHRA	Access Generic Medicines Work Sharing Initiative	Final	Application Process, Procedural, Generics,
UK	MHRA	Access New Active Substance (NAS) Work Sharing Initiative	Final	Application Process, Procedural
UK	MHRA	Access Consortium	Final	Procedural, Administrative
UK	MHRA	Guidance on Project Orbis	Final	Application Process, Oncology
US	FDA	IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations - Guidance for Sponsor-Investigators	Draft	Administrative, Procedural
US	FDA	Consumer Antiseptic Rub Final Rule Questions and Answers - Guidance for Industry	Final	Over-The-Counter Drugs
US	FDA	Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry	Final	Electronic Submissions, Application Process, Procedural, Labeling, Safety, Pharmacovigilance
US	FDA	Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency - Guidance for Industry	Final	Application Process, Procedural
US	FDA	Dry Eye: Developing Drugs for Treatment - Guidance for Industry	Draft	Clinical/Medical
US	FDA	Controlled Correspondence Related to Generic Drug Development - Guidance for Industry	Final	Generic Drugs
US	FDA	Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products: Draft Guidance for Industry	Draft	Drug Safety, Labeling, Procedural
US	FDA	Best Practices in Developing Proprietary Names for Human Prescription Drug Products - Guidance for Industry	Final	Drug Safety, Labeling, Procedural
US	FDA	Human Gene Therapy for Neurodegenerative Diseases - Draft Guidance for Industry	Draft	Cellular and Gene Therapy, Advanced Therapies
US	FDA	Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion - Guidance for Industry	Final	Blood Products
US	FDA	Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products - Guidance for Industry	Final	Clinical, Medical, Clinical Trials
US	FDA	Requesting FDA Feedback on Combination Products - Guidance for Industry and FDA Staff	Final	Combination Products
US	FDA	Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional Review Boards	Final	Clinical, Medical, Clinical Trials
US	FDA	Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis - Guidance for Industry	Final	Blood Products
US	FDA	Compliance Policy Guide CPG Sec. 110.650 Weekly Entry Filing - Guidance for Industry and FDA Staff	Final	Compliance, Export, Import

Global Pharma Guidance Tracker – December 2020

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