Pharma Guidance Tracker - January 2016

Country

Organization

Document

Status

International

AHWP

Regulation of Combination Products – a Review of International Practice

Final

International

ICH

Guideline on Genomic Sampling and Management of Genomic Data E18

Draft

International

ICH

ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: Questions & Answers (R3)

Final

International

ICMJE

Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals

Draft

International

WHO

Labelling information of inactivated influenza vaccines for use in pregnant women

Draft

Canada

HC

S10: Photosafety Evaluation of Pharmaceuticals

Final

Canada

HC

S9: Nonclinical Evaluation for Anticancer Pharmaceuticals

Final

Canada

HC

S8: Immunotoxicity Studies For Human Pharmaceuticals

Final

Canada

HC

S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Final

Canada

HC

S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

Final

Canada

HC

M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Final

Canada

HC

M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Final

Canada

HC

M3(R2) Q&A(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Final

EU

CMDh

Decentralised Procedure Members States' Standard Operating Procedure (Track version)

Final

EU

EMA

Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Final

EU

EMA

Draft guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin

Draft

EU

EMA

Draft guideline on core SmPC and Package Leaflet for gadopentetate dimeglumine

Draft

EU

EMA

Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias

Draft

EU

EMA

Lessons learned from the review of the labelling of centrally authorised pandemic vaccines

Final

EU

EMA

Qualification opinion on paediatric ulcerative colitis activity index (PUCAI)

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), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance

Final

EU

EMA

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

Final

EU

EMA

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes

Final

EU

EMA

Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure: document with track changes

Final

EU

EMA

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

Final

EU

EMA

Member States' contact points for translation review (v.6.1)

Final

EU

EMA

Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha

Draft

EU

EUnetHTA

HTA Core Model: Guiding principles on use

Final

Ireland

HPRA

Guide to Fees for Human Products

Final

Ireland

HPRA

Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland

Final

South Africa

MCC

Labelling of medicines containing sugars

Final

South Africa

MCC

Multiple submissions of the same application for registration with different proprietary names

Final

US

FDA

Draft Guidance on Lamotrigine

Draft

US

FDA

Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products

Final

US

FDA

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Final

US

FDA

Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under 361 of the Public Health Service Act and 21 CFR Part 1271

Draft

US

FDA

Product-Specific Recommendations for Generic Drug Development

Draft