Global Pharma Guidance Tracker – December 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Click on the links to access the documents. The complete Global Pharma Guidance Tracker with sortable and searchable listings going back to 2014 is available on online.

 

Country	Organization	Document	Status	Category
International	WHO	Revision of the Monograph on Ethinylestradiol (Ethinylestradiolum): Draft proposal for inclusion in The International Pharmacopoeia (QAS18/781)	Draft	Safety
International	WHO	Polymorphism: Draft chapter for The International Pharmacopoeia	Draft	Safety
Australia	TGA	Fees and charges proposal 2019-20	Draft	Procedural, Application Process
Australia	TGA	Medicine shortages/discontinuations – Electronic notification form: User guide	Final	Compliance
Australia	TGA	Guidance for TGO 101: Standard for tablets, capsules and pills	Draft	Safety, Quality
Australia	TGA	Special Access Scheme & Authorised Prescriber Scheme online system	Final	Special Access
Canada	HC	Release of ICH Q3C(R7): Impurities: Guideline for Residual Solvents	Final	Quality
EU	EC	Medicinal Products for Human Use Containing or Consisting of GMOs: Interplay Between the EU Legislation on Medicinal Products and GMOs: Frequently Asked Questions	Final	Clinical Trials
EU	EDQM	Certification of Suitability to Monographs of the European Pharmacopoeia Guidance on applications for sister files (PA/PH/CEP (09) 141, 2R)	Final	Quality, Safety, Efficacy
EU	EDQM	Certification of suitability to the Monographs of the European Pharmacopoeia Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure (PA/PH/CEP (13) 110, 2 R)	Final	Quality, Safety, Efficacy
EU	EDQM	Certification of suitability to Monographs of the European Pharmacopoeia: Certification Policy Document - Content of the dossier for chemical purity and microbiological quality (PA/PH/CEP (04) 1, 6R)	Final	Quality, Safety, Efficacy
EU	CMDh	CMS validation checklist in MRP (CMDh/387/2018)	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)	Final	Variations
EU	CMDh	Q&A – QP Declaration (CMDh/340/2015/Rev.5)	Final	Quality, Safety
EU	CMDh	Template of letter of intent for the submission of a worksharing procedure	Final	Procedural
EU	CMDh	Template for Day 120/Day 180 Quality Assessment Report (CMDh/209/2005, Rev.5)	Final	Procedural
EU	CMDh	Template for Day 145 Concerned Member State Comments (CMDh/212/2005, Rev.5)	Final	Procedural
EU	CMDh	Template for Day 205 Concerned Member State comments (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	Annex-2 Template for the Applicant declaration for inclusion of mobile technology feature in MRP/DCP procedures	Final	Labeling
EU	CMDh	List of safety concerns per approved Risk Management Plan (RMP) of active substances per product (Doc. Ref: CMDh/330/2015, Rev.18)	Final	Safety, Pharmacovigilance
EU	CMDh	Labelling for multi-language packages (CMDh/351/2017, Rev.1)	Final	Labeling
EU	EMA	Concept paper on a guideline for allergen products development in moderate to low-sized study populations (EMA/CHMP/251023/2018)	Draft	Product Development, Clinical
EU	EMA	Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2 (EMA/CHMP/BPWP/144552/2009 rev. 2 Corr. 1)	Draft	Clinical Trials, Product Development
EU	EMA	List of European Union reference dates and frequency of submission of periodic safety update reports (EMA/630645/2012 Rev. 76)	Final	Safety, Pharmacovigilance
EU	EMA	List of medicinal products under additional monitoring (EMA/245297/2013 Rev.62)	Final	Inspection, Pharmacovigilance
EU	EMA	Wheat starch (containing gluten) used as an excipient Report published in support of the ‘Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use’ EMA/CHMP/704219/2013 (EMA/CHMP/639441/2013 corr. 2*)	Final	Safety
EU	EMA	Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) (EMA/INS/GCP/856758/2018)	Final	Clinical Trials, Inspections
EU	EMA	Q&A: Good clinical practice (GCP)	Final	Clinical Trials
EU	EMA	Cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 mg and 80 mg product-specific bioequivalence guidance (EMA/CHMP/790333/2018)	Draft	Product-specific guidance
EU	EMA	Ezetimibe tablet 10 mg product-specific bioequivalence guidance (EMA/CHMP/802491/2018)	Draft	Product-specific guidance
EU	EMA	Guideline on Active Substance Master File Procedure (CHMP/QWP/227/02 Rev 4)	Final	Quality, Safety, Efficacy
EU	EMA	Draft guideline on quality and equivalence of topical products (CHMP/QWP/708282/2018)	Draft	Quality, Efficacy
EU	EMA	Brexit-related guidance for companies	Final	Procedural
EU	EMA	Clinical Trial Regulation	Final	Clinical Trials
EU	EMA	Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance (EMA/CHMP/800775/2017)	Final	Product-specific guidance
EU	EMA	Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance (EMA/CHMP/291450/2018)	Final	Product-specific guidance
EU	EMA	Explanatory note – letter of representation: Referral procedure under Article 31 of Directive 2001/83/EC	Final	Procedural
EU	EMA	Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation (EMA/CHMP/458101/2016)	Final	Modeling, Simulation
EU	EMA	Guide on access to unpublished documents (EMA/304162/2014 Rev.1)	Final	Procedural
EU	EMA	Timetable: Annual renewal application of conditional marketing authorisation (EMA/823131/2015 Rev.2)	Final	Procedural
EU	EMA	Quality of medicines: Questions and Answers	Final	Quality
EU	EMA	Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products: General principles of acceptability and rules of procedure (EMA/493897/2015 Rev. 1)	Final	Labeling
EU	EMA	Member states contact points for review of national versions of the content of mobile scanning and other technologies (EMA/358267/2015, Version 4)	Final	Labeling, Procedural
EU	EMA	Request/declaration form for the provision of information via mobile scanning and other technologies in the centralised procedure (EMA/493921/2015 Rev.1)	Final	Labeling, Procedural
EU	EMA	EudraVigilance Registration: Frequently Asked Questions - Information on creating and maintaining EV user accounts using IAM2 (EMA/404930/2018)	Final	Pharmacovigilance
EU	EMA	Clinical pharmacology and pharmacokinetics: Questions and Answers	Final	Safety, Efficacy
EU	EMA	Launch of the new EudraVigilance system: Questions and Answers from Stakeholders - Version 1.7 (EMA/679813/2018)	Final	EudraVigilance, Pharmacovigilance
EU	EMA	Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken (EMA/CHMP/CVMP/3Rs/677407/2015)	Final	Product Development
EU	EMA	European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (EMA/821278/2015) [Track version]	Final	Procedural
EU	EMA	European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMEA-H-19984/03 Rev. 79) [Track version]	Final	Procedural
Finland	Fimea	Notifications of the safety features appearing on the packaging of medicinal products	Final	Labeling
Ireland	HPRA	Guide to New Applications and Variations to Wholesale Distribution Authorisations (AUT-G0152-1)	Final	Procedural
Latvia	SAM	Information on Submissions of Marketing Authorisation Documentation in eCTD Format	Final	Application Process, Procedural
Switzerland	Swissmedic	Correction of the new eCTD specification documents Swiss M1 Specification and Swiss eCTD Validation Criteria	Final	Application Process, Procedural
Switzerland	Swissmedic	Reclassification of medicinal products from dispensing category D to E	Final	Prescribing
Switzerland	Swissmedic	Updated procedure for submitting applications according to HMV4 before 01.01.2019	Final	Procedural
Tanzania	TFDA	Payment of annual retention fees for the year 2019	Final	Procedural
UK	MHRA	Conversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs)	Final	Application Process, Procedural
UK	MHRA	Valproate use by women and girls	Final	Safety
UK	MHRA	Clinical trials for medicines: Manage your authorisation, report safety issues	Final	Clinical Trials
US	FDA	Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data: Guidance for Industry and Other Stakeholders	Draft	Procedural
US	FDA	Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry	Final	Clinical Trials
US	FDA	Data Integrity and Compliance With Current Good Manufacturing Practice - Questions and Answers: Guidance for Industry	Final	Pharmaceutical Quality, Manufacturing Standards, cGMP
US	FDA	Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff	Draft	Drug Development Tools
US	FDA	The "Deemed to be a License" Provision of the BPCI Act: Questions and Answers - Guidance for Industry	Draft	Procedural
US	FDA	Interpretation of the "Deemed to be a License" Provision of the Biologics Price Competition and Innovation Act of 2009: Guidance for Industry	Final	Procedural
US	FDA	New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2): Guidance for Industry	Draft	Biosimilarity
US	FDA	Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry	Final	Biosimilars
US	FDA	Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act	Draft	Compounding, Pharmaceutical Quality, Manufacturing Standards, cGMP
US	FDA	Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment - Guidance for Industry	Draft	Clinical, Medical
US	FDA	Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry	Final	Generics, User Fees
US	FDA	Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry	Final	Blood
US	FDA	Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products: Guidance for Industry	Draft	Labeling
US	FDA	Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry	Draft	Blood

Key:

WHO: World Health Organization

TGA: Therapeutic Goods Administration

HC: Health Canada

EC: European Commission

EDQM: European Directorate for the Quality of Medicines and Healthcare

CMDh: Coordination Group for Mutual Recognition and Decentralised Procedures – Human

EMA: European Medicines Agency

Fimea: Finnish Medicines Agency

HPRA: Health Products Regulatory Authority

SAM: State Agency of Medicines

Swissmedic: Swiss Agency for Therapeutic Products

TFDA: Tanzania Food and Drugs Authority

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration

 

From the editors of Scrip Regulatory Affairs.