EMA: Scientific guideline: Concept paper on revision of note for guidance for the determination of withdrawal periods for milk, draft

In 2000 the note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98-FINAL) was adopted by the CVMP. Paragraph 2.1.10. thereof addresses dry cow products. Dry cow ...

EMA: Scientific guideline: ICH guideline Q4B annex 7 (R2) on dissolution test – general chapter

This annex is the result of the Q4B process for Dissolution Test. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...

EMA: Biosimilar medicines

A similar biological or \'biosimilar\' medicine is a biological medicine that is similar to another biological medicine (the ‘biological reference medicine’) that has already been authorised ...

EMA: Scientific guideline: Draft guideline on similar biological medicinal products containing monoclonal antibodies, draft

This guideline lays down the non-clinical and clinical requirements for monoclonal antibody (mAb) containing medicinal products claiming to be similar to another one already marketed. The ...

EDQM: A Council of Europe Convention to fight against counterfeit medical products

Strasbourg, 09.12.2010 – The Council of Europe Committee of Ministers adopted a convention which, for the first time, criminalises the counterfeiting and also manufacturing and supplying of ...

European Commission: ICH guideline E2F - Note for guidance on development safety update reports

The ICH guideline E2F gives sponsors guidance as to how to draw up the yearly safety report (Article 17(2) of the \'Clinical Trials Directive\' 2001/20/EC). To give additional support, ICH has ...

MHRA: Marketing authorisations for medicines: Decentralised Procedure slot update (December 2010) – slots available in all therapeutic areas in 2011

The MHRA has slots available in all therapeutic areas, including biologicals and over-the-counter (OTC) in 2011. Companies are advised to contact the MR-DC team to enquire about ...

FDA: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. The guidance ...

Polish Ministry of Health: Regulation concerned clinical trial application forms and fees.

Regulation concerned clinical trial application forms, final reports and fees for submission each application form and application form for variation. ...

EMA: Regulatory and procedural guideline: Concept Paper on the Revision of Chapter 6 of the EU GMP Guide Quality Control, draft.

Chapter 6 of the EU GMP guide provides general guidance on the Quality Control Department and Good Quality Control Laboratory Practice including specific aspects for documentation, sampling and ...

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