Country	Organization	Document	Status	Category
International	PIC/S	PIC/S Guidance on Classification of GMP Deficiencies (PI 040-1)	Final	Manufacturing
International	PIC/S	Guidelines for Accession to the Pharmaceutical Inspection Co-operation Scheme	Final	Procedural
Australia	TGA	Regulatory options for appropriate access and safety controls for alkyl nitrite	Final	Safety
Australia	TGA	Options for the Regulation of Faecal Microbiota Transplantation materials	Draft	Safety
Australia	TGA	Process validation for listed and complementary medicines: Technical guidance on the interpretation of the PIC/S Guide to GMP	Final	Manufacturing
Australia	TGA	Ongoing stability testing for listed and complementary medicines: Technical guidance on the interpretation of the PIC/S Guide to GMP	Final	Manufacturing
Australia	TGA	Medicinal gases guidance: Technical guidance on the interpretation of the PIC/S Guide to GMP	Final	Manufacturing
Australia	TGA	GMP clearance guidance (Version 18.1)	Final	Manufacturing
Australia	TGA	Reformatting Product Information: Frequently asked questions	Final	Product Information
Australia	TGA	Advertising: Questions and answers on the Advertising Code	Final	Advertising, Promotion
Belgium	FAHMP	Notifications about anti-tampering device (ATD) or devices to prevent tampering on packaging of existing drugs that do not fall under the Falsified Medicines Directive	Final	Packaging, Labeling
Belgium	FAHMP	eCTD format required for all procedures	Final	Procedural, Application Process
Canada	HC	Draft Guidance Document - Regulatory requirements for Drug Identification Numbers (DINs)	Draft	Procedural
Canada	HC	Proposed new regulatory activity types for transactions filed to the Marketed Health Products Directorate (MHPD)	Draft	Procedural, Application Process
Estonia	SAM	Reminder to marketing authorisation holders and manufacturers of medicines concerning the rules of safety features	Final	Packaging, Labeling
EU	EC	Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules for Medicinal Products for Human Use and veterinary medicinal products	Final	Procedural
EU	EC	Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure (Rev 04)	Final	Procedural
EU	EC	EU guidelines for Good Manufacturing Practice: Annex 2 - Manufacture of Biological active substances and Medicinal Products for Human Use	Final	Manufacturing
EU	EC	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 (ENTR/6283/00 Rev 5)	Draft	Procedural
EU	EC	Safety Features for Medicinal Products for Human Use: Questions and Answers (Ver 13)	Final	Packaging, Labeling
EU	EC	Inspection Report Format: Member States Supervision of the National Medicines Verification Systems/National Medicines Verification Organisations	Final	Packaging, Labeling, Inspections
EU	EDQM	Guide for the elaboration and use of monographs on vaccines and immunosera for human use	Final	Quality, Safety, Efficacy
EU	EDQM	Guide for the elaboration of monographs on radiopharmaceutical preparations	Final	Quality, Safety, Efficacy
EU	CMDh	Notice to stakeholders on the withdrawal of the United Kingdom and EU rules for national authorised medicinal products for human use (CMDh/360/2017, Rev. 2) [Track version]	Final	Procedural
EU	CMDh	Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human use (CMDh/361/2017, Rev.3) [Track version]	Final	Procedural
EU	CMDh	Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (CMDh/373/2018, Rev.2) [Track version]	Final	Procedural
EU	CMDh	CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008	Final	Variations
EU	CMDh	Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008 (CMDh/132/2009/Rev.52) [Track version]	Final	Variations
EU	CMDh	Q&A – QP Declaration (CMDh/340/2015/Rev.5) [Track version]	Final	Manufacturing, Procedural
EU	CMDh	Template of letter of intent for the submission of a worksharing procedure	Final	Procedural
EU	CMDh	Template for RMS Day 120/Day 180 Draft Assessment Report (CMDh/209/2005, Rev.5)	Final	Procedural
EU	CMDh	Template for Concerned Member State Comments on Day 120 Draft Assessment Report (CMDh/212/2005, Rev.5)	Final	Procedural
EU	CMDh	Template for Concerned Member State Comments to be sent at Day 205 (CMDh/215/2005, Rev.5)	Final	Procedural
EU	CMDh	CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product (CMDh/313/2014, Rev.8) [Track version]	Final	Labeling
EU	CMDh	Template: Application for the Inclusion of Mobile Technology Feature in MRP/DCP Procedures	Final	Labeling
EU	EMA	Electronic product information for human medicines in the EU – Draft key principles (EMA/849614/2018)	Draft	Labeling, Product Information
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev.63)	Final	Inspection, Pharmacovigilance
EU	EMA	List of centrally authorised products requiring a notification of a change for update of annexes (EMA/14676/2019)	Final	Procedural, Product Information
EU	EMA	Questions & answers on signal management (EMA/261758/2013 Rev 3)	Final	Safety, Pharmacovigilance
EU	EMA	Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/755489/2018)	Draft	Product Development
EU	EMA	Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/844951/2018 Rev. 3)	Draft	Antibiotics, Product Development
EU	EMA	Manufacturer organisations in the OMS dictionary (EMA/465039/2018)	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/836074/2018)	Final	Packaging, Labeling
Ireland	HPRA	EU Falsified Medicines Legislation – Update on National Arrangements for Implementation	Final	Packaging, Labeling
Malaysia	NPRA	Drug Registration Guidance Document (DRGD)	Final	Procedural, Application process
Malaysia	NPRA	Guidance Document on Verification of Translated Official Document	Final	Procedural
Saudi Arabia	SFDA	Guidance for Graphic Design of Medication Packaging (Version 2.0)	Final	Packaging, Labeling
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore (TPB-GN-005-005)	Final	Procedural, Application Process
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore – Patent Declaration Forms	Final	Procedural, Application Process
Singapore	HSA	Guidance on Therapeutic Product Registration in Singapore – Guideline on Drug Master File (DMF)	Final	Procedural, Application Process, Safety
Singapore	HSA	DMF Submission Form Template	Final	Procedural, Application Process, Safety
Singapore	HSA	MIV Enquiry and Submission Form Template	Final	Procedural, Variations
Singapore	HSA	Guideline on Minor Variation Applications for Chemical Therapeutic Products	Final	Procedural, Variations
Singapore	HSA	Checklist on Dossier Requirements for MIV-1 Variation	Final	Procedural, Variations
Singapore	HSA	Checklist on Dossier Requirements for MIV-2 (Notification) Variation	Final	Procedural, Variations
Singapore	HSA	Do-and-Tell MIV-2 Quick guide	Final	Procedural, Variations
Singapore	HSA	Checklist on Dossier Requirements for MIV-2 (Do-And-Tell) Variation	Final	Procedural, Variations
Singapore	HSA	Guideline on Minor Variation Applications for Biological Therapeutic Products	Final	Procedural, Variations
Singapore	HSA	Checklist on Dossier Requirements for MIV-1 Variation for Biological Therapeutic Products	Final	Procedural, Variations
Singapore	HSA	Checklist on Dossier Requirements for MIV-2 (Notification) Variation for Biological Therapeutic Products	Final	Procedural, Variations
Singapore	HSA	Checklist on Dossier Requirements for MIV-2 (Do-and-Tell) Variation for Biological Therapeutic Products	Final	Procedural, Variations
Singapore	HSA	Import and Supply of an Unregistered Therapeutic Product for Patients' Use	Final	Compassionate Use
Switzerland	Swissmedic	Adaptation of the form Information for application Art.13 TPA HMV4	Final	Procedural
Switzerland	Swissmedic	Modified ordering requirements for export certificates (FSC)	Final	Procedural
Switzerland	Swissmedic	Publication of the corrected eCTD specification documents	Final	Procedural, Application Process
UK	HRA	Public Co-Applicants in Research – guidance on roles and responsibilities	Final	Clinical Investigation
UK	MHRA	Brexit: MHRA guidance and publications on a possible no deal scenario	Final	Procedural
UK	MHRA	Good pharmacovigilance practice (GPvP)	Final	Pharmacovigilance
UK	MHRA	Brexit: Contingency legislation covering regulation of medicines and medical devices in a no deal scenario	Final	Procedural
UK	MHRA	Making a success of Brexit	Final	Procedural
UK	MHRA	Medicines: application forms for a manufacturer licence	Final	Procedural, Application Process, Manufacturing
UK	MHRA	Brexit: EU guidance documents referred to in the Human Medicines Regulations 2012	Final	Procedural
UK	MHRA	How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal	Final	Procedural
UK	MHRA	Medicines: reclassify your product	Final	Switching
UK	MHRA	Brexit: Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letter to industry	Final	Procedural
UK	MHRA	Medicines: register as a broker	Final	Procedural
UK	MHRA	Implementing the Falsified Medicines Directive: Safety Features	Final	Packaging, Labeling
UK	MHRA	Good laboratory practice (GLP) for safety tests on chemicals	Final	Safety
UK	MHRA	Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal	Final	Procedural
US	FDA	Rare Diseases: Common Issues in Drug Development - Guidance for Industry	Draft	Rare Diseases
US	FDA	Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format: Guidance for Industry	Draft	Procedural
US	FDA	Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products: Guidance for Industry	Final	Procedural
US	FDA	Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry	Final	Electronic Submissions
US	FDA	REMS Assessment: Planning and Reporting: Guidance for Industry	Draft	Procedural
US	FDA	Survey Methodologies to Assess REMS Goals That Relate to Knowledge: Guidance for Industry	Draft	Procedural
US	FDA	Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection: Guidance for Industry	Final	Pharmaceutical Quality/CMC
US	FDA	S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicine: Core Guideline	Draft	ICH, Safety
US	FDA	Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway: Guidance for Industry	Final	Labeling
US	FDA	ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry	Draft	Generics

Global Pharma Guidance Tracker – January 2019

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