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Pharma guidance tracker - July 2015

This article was originally published in SRA

06 Aug 2015
News

Neena Brizmohun @ScripRegNeena [email protected]

Click on the links to access the documents.

Country	Organization		Status
International	ICH	Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic risk – Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes	Draft
International	ICH	Impurities: Guideline for Residual Solvents PDE for Triethylamine and PDE of Methylisobutylketone	Draft
International	ICH	Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)	Draft
Canada	HC	Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall)	Final
Egypt	EDA	Prescription Medicine Promotion guidelines	Draft
EU	EMA	Questions and answers on boric acid in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’	Draft
EU	EMA	Questions and answers on sodium laurilsulfate in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’	Draft
EU	EMA	Q3C (R6): Impurities: guideline for residual solvents - Step 2b	Draft
EU	EMA	ICH guideline M8 on eCTD – questions and answers - Step 5	Final
EU	EMA	ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers - Step 5	Final
EU	EMA	Reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus	Draft
EU	EMA	Guideline on influenza vaccines – submission and procedural requirements	Final
EU	EMA	Compilation of individual product-specific guidance on demonstration of bioequivalence rev 2	Final
EU	EMA	Capecitabine film-coated tablets 150, 500 mg product-specific bioequivalence guidance	Final
EU	EMA	Day 80 assessment report non-clinical and clinical guidance - generics rev05.15	Final
EU	EMA	Guideline on manufacture of the finished dosage form	Draft
EU	EMA	Application form - User guide for the electronic application form for a marketing authorisation	Final
EU	EMA	Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance	Draft
EU	EMA	Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance	Draft
EU	EMA	Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance	Draft
EU	EMA	Zonisamide hard capsules 25, 50 and 100 mg, orodispersible tablets 25, 50, 100 and 300 mg product-specific bioequivalence guidance	Draft
EU	EMA	Reflection paper on the use of cocrystals of active substances in medicinal products	Final
EU	EMA	Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage form	Draft
EU	EMA	Recommendation to marketing authorisation holders, highlighting recent updates for reduction, refinement and replacement (3Rs) methods described in the European Pharmacopoeia – applicable to human vaccines against hepatitis A	Final
EU		Guideline on core SmPC and package leaflet for sodium fluoride (18F)	Final
EU	EMA	Calculating 'chargeable units' for pharmacovigilance fees as specified in Regulation (EU) No 658/2014: guidance on how 'chargeable units' are derived from medicinal product information held within the 'Article 57' database	Final
EU	EMA	Draft qualification opinion – Total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)	Draft
EU	EMA	Concept paper on the need for a single note for guidance on the chemistry of active substances	Draft
EU	EMA	Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party	Final
EU	EMA	Guideline on core summary of product characteristics (SmPC)for human fibrinogen products	Final
EU	EMA	Guideline on the clinical investigation of hepatitis B immunoglobulins	Final
EU	EMA	Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)	Final
EU		Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal products	Final
EU	EMA	Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004	Draft
EU	EMA	Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004	Draft
EU	EMA	European Medicines Agency regulatory tools for early access to medicines	Draft
	EMA	Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor	Draft
EU	EMA	Guideline on the processing of renewals in the centralised procedure	Draft
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
New Zealand	Medsafe	Current Guidelines on the Regulation of Therapeutic Products in New Zealand - Part C: Requirements for application types	Final
Saudi Arabia	SFDA	SFDA Regulations & Requirements for Conducting Clinical Trials on Drugs	Final
US	FDA	Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3	Draft
US	FDA	Request for Quality Metrics	Draft
US	FDA	Analytical Procedures and Methods Validation for Drugs and Biologics	Final
US	FDA	Testicular Toxicity: Evaluation During Drug Development	Draft
US	FDA	Qualification of Biomarker – Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease	Draft
US	FDA	Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation	Final

Key

ICH: International Conference on Harmonisation

HC: Health Canada

EDA: Egyptian Drug Authority

EMA: European Medicines Agency

SFDA: Saudi Food & Drug Authority

FDA: Food and Drug Administration

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Pharma guidance tracker - July 2015

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Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says

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Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire

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