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Pharma Guidance Tracker - October/November 2015

This article was originally published in SRA

  • News

Click on the links to access the documents.

Country Organization Document Status
International WHO Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations(Proposed revision of WHO TRS 924, Annex 1) Draft
International WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines(Replacement of TRS 962, Annex 1) Final
International WHO WHO GMP for Biological Products(Proposed replacement of TRS 822, Annex 1) Final
International WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions Final
International WHO Regulatory assessment of approved rDNA-derived biotherapeutics(proposed addendum to WHO TRS 987, Annex 4) Final
International WHO Procedural Guidance on submitting variations to a prequalified product Final
International PIC/S PIC/S GMP Guide(PE 009-12) Final
Australia TGA Australian regulatory guidelines for OTC medicines Final
Australia TGA Evidence of GMP compliance for prescription medicines Final
Australia TGA Revised edition of the Uniform Recall Procedure for Therapeutic Goods Draft
Belgium FAMHP New definition of the approval date in SmPC and leaflet Final
Belgium FAMHP eSubmission Guidelines: New ways of working at FAMHP (Version 2.13) Final
Canada HC Updates to the Guidance Document: Fees for the Review of Drug Submissions and Applications Final
Canada HC Release of Draft (Step 2) International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E6 Integrated Addendum: Good Clinical Practice Draft
Canada HC Update: Implementation of Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document: Product Monograph Final
Canada HC Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use Draft
Canada HC Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format Final
Denmark DMA Summary of product characteristics and package leaflet to be updated after the establishment of DKMA Final
Denmark DMA Guidelines on applications for authorisation to manufacture and import medicines and intermediates Final
EU EC EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 16: Certification by a Qualified Person and Batch Release(Ref. Ares(2015)4234460) Final
EU EDQM Certification of suitability to the Monographs of the European Pharmacopoeia: Changes in contact details to be notified to EDQM(PA/PH/CEP (10) 86 1R) Final
EU EDQM Certification of suitability to the Monographs of the European Pharmacopoeia: Complaints Procedure(PA/PH/CEP (15) 19) Final
EU EMA Guideline on non-clinical local tolerance testing of medicinal product(EMA/CHMP/SWP/2145/2000 Rev. 1) Final
EU EMA Risk minimisation strategy for high-strength and fixed combination insulin products: Addendum to the good practice guide on risk minimisation and prevention of medication errors(EMA/686009/2014) Final
EU EMA Good practice guide on recording, coding, reporting and assessment of medication errors(EMA/762563/2014) Final
EU EMA Guidance on prevention of medication errors with high-strength insulins(EMA/134145/2015) Final
EU EMA Good practice guide on risk minimisation and prevention of medication errors(EMA/606103/2014) Final
EU EMA Guidance on prevention of medication errors with diabetes medicines containing insulin and a non-insulin active substance(EMA/134144/2015) Final
EU EMA Post-orphan medicinal product designation procedures(EMA/62801/2015) Final
EU EMA List of centrally authorised products requiring a notification of a change for update of annexes(EMA/741662/2015) Final
EU EMA Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products(EMA/CHMP/281371/2013) Final
EU EMA Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis(EMA/CHMP/239770/2014 Rev. 2) Final
EU EMA Guidance for companies considering submission to the adaptive pathways pilot(EMA/707235/2015) Final
EU EMA Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004 - Chapter 3.II: XEVPRM User Guidance(EMA/135580/2012) Final
EU EMA Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use(EMA/CHMP/SWP/272921/2012) Final
EU EMA Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism in non-surgical patients - formerly CPMP/EWP/6235/04 Rev.1(EMA/CHMP/41252/2015) Draft
EU EMA Total Kidney Volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)(EMA/CHMP/SAWP/473433/2015) Final
EU EMA Dossier requirements for Centrally Authorised Products(EMA/497021/2012 Rev. 22) Final
EU EMA Dossier requirements for referral, ASMF and NAP submissions (PASS107, Workshare, Signal Detection procedures) and ancillary medicinal substances in a medical device(EMA/13015/20144 Rev. 2) Final
EU EMA Pre-notification check for Type IB Variations(EMA/413829/2015) Final
EU EMA European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure(EMA/339324/2007) Final
EU EMA European Medicines Agency post-authorisation procedural advice for users of the centralised procedure(EMEA-H-19984/03 Rev. 55) Final
EU EMA Scientific guidance on post-authorisation efficacy studies
(EMA/PDCO/CAT/CMDh/PRAC/CHMP/
261500/2015)		 Draft
EU EMA Presubmission guidance: questions 45 to 56 Final
EU EMA Presubmission guidance: questions 34 to 44 Final
EU EMA Presubmission guidance: questions 57 to 67 Final
EU EMA Type-IB variations: questions and answers Final
EU EMA Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)(EMA/CHMP/57760/2015) Draft
EU EMA Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 Chapter 5: eXtended EudraVigilance Product Report Acknowledgement Message(EMA/718844/2011) Final
EU EMA Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man: Condition Specific Guidance(EMA/CHMP/703715/2012 Rev. 1) Final
EU EMA M4E(R2) - Common technical document for the registration of pharmaceuticals for human use – Efficacy(EMA/CPMP/ICH/2887/1999) Draft
EU EMA Rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg: Product-specific bioequivalence guidance(EMA/CHMP/PKWP/151340/2015) Draft
EU EMA Tacrolimus granules for oral suspension 0.2 and 1 mg: Product-specific bioequivalence guidance(EMA/CHMP/PKWP/36648/2015) Draft
EU EMA Entecavir film-coated tablets 0.5 and 1 mg, oral solution 0.05mg/ml: Product-specific bioequivalence guidance(EMA/CHMP/PKWP/151748/2015) Draft
EU EMA Lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg: Product-specific bioequivalence guidance (EMA/CHMP/PKWP/152216/2015) Draft
EU EMA Ticagrelor film-coated tablets 90mg: Product-specific bioequivalence guidance(EMA/CHMP/PKWP/151478/2015) Draft
EU EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins(EMEA/CHMP/BMWP/14327/2006 Rev. 1) Draft
Hong Kong PPB Guidance Notes for Registration of Biosimilar Products Final
Ireland HPRA Guide to Information held by the HPRA Final
Ireland HPRA Guide to Biosimilars for Healthcare Professionals and Patients Final
Netherlands MEB Changes in policy on nomenclature of medicinal products Final
Netherlands MEB Changes in policy on product information Final
New Zealand Medsafe Guidelines on the Regulation of Therapeutic Products in New Zealand - Part 5: Labelling of medicines and related products Final
Saudi Arabia SFDA Regulatory Framework for Drug Approvals, Version 5.0 Final
Saudi Arabia SFDA GCC Module 1 Specifications, Version 1.5 Final
Saudi Arabia SFDA Guidance for naming of medicinal product, Version 1.0 Draft
Saudi Arabia SFDA Guidance for Graphic Design of medication packaging, Version 1.0 Draft
South Africa MCC Reporting of post-marketing adverse drug reactions to human medicinal products in South Africa Draft
Switzerland Swissmedic Change in practice for variations requiring notification Final
Switzerland Swissmedic HD-Guidance document: Formal requirements Final
UK MHRA Baseline guidance for medicine licence submissions Final
UK MHRA What is a biosimilar medicine? Final
UK MHRA Clinical trials: How NHS trusts and health boards can maintain compliant electronic health record systems Final
UK MHRA MHRA phase I accreditation scheme Final
UK MHRA Cancel a medicine's marketing authorisation or other licence Final
US FDA Certification Process of Designated Medical Gases Draft
US FDA Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Labeling for Products That Contain Acetaminophen Final
US FDA Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants Final
US FDA Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment Final
US FDA Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND Final
US FDA Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation Draft
US FDA DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Final
US FDA Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route Final
US FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Draft
US FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Draft
US FDA Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Final
US FDA Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Draft
US FDA Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act Final
US FDA Integrated Summary of Effectiveness Final
US FDA Acceptability of Draft Labeling to Support ANDA Approval Final

Key

WHO: World Health Organization

PIC/S: Pharmaceutical Inspection Co-operation Scheme

TGA: Therapeutic Goods Administration

FAMHP: Federal Agency for Medicines and Health Products

HC: Health Canada

DMA: Danish Medicines Agency

EC: European Commission

EDQM: European Directorate for the Quality of Medicines & Healthcare

EMA: European Medicines Agency

PPB: Pharmacy and Poisons Board

HPRA: Health Products Regulatory Authority

MEB: Medicines Evaluation Board

Medsafe: Medicines and Medical Devices Safety Authority

SFDA: Saudi Food and Drug Authority

MCC: Medicines Control Council

Swissmedic: Swiss Agency for Therapeutic Products

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration

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