EMA: Guideline on the conduct of bioequivalence studies for veterinary medicinal products

It is the objective of this guidance to specify requirements for the design, conduct, and evaluation of bioequivalence studies for pharmaceutical forms with systemic action. In addition, guidance ...

GMP: New Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal products (NIMPs)

This document intends to clarify and provide additional guidance on the definition of IMP and to provide specific guidance about the use of non-investigational medicinal products (NIMPs), in ...

GMP: New answers published about Variations: EMA\'s updated

The European Medicines Agency (EMA) offers a Q&A page which contains a collection of questions and answers on all regulatory activities linked to the issue of drug marketing authorisations. This ...

EMA: Procedural advice on fee reductions for designated orphan medicinal products

Orphan medicinal products designated in accordance with Regulation (EC) No 141/2000 of 22 January 2000, are eligible for reductions on all fees payable under Union rules pursuant to Regulation ...

Polish Office of Registration: Statement amending Ordinance on the fees payable in relation to placing medicinal product on the market came into force on 06.04.2011

The President of the Office for Registration of Medicinal Products, Medical Cevices and Biocidal Products hereby informs that Ordinance of the Minister of Health of 02.03.2011 amending Ordinance ...

FDA: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act

This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)), added by section 901 of the Food and Drug ...

EMA: Draft guideline on requirements for the production and control of immunological veterinary medicinal products

This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). The guideline outlines important items ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

EMA: ICH Topic Q3C (R5) Impurities: Guideline for residual solvents

The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and ...

EMA: Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance

This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical ...

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