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EMA: Regulatory and procedural guideline: Annex I variation application(s) content for live attenuated influenza vaccines, draft

19.12.2010
MAHs shall submit a Type II variation application containing the adequate quality documentation in accordance with Article 18 of Commission Regulation (EC) No 1234/2008, by the Agency recommended ...

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

19.12.2010
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

19.12.2010
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

19.12.2010
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

19.12.2010
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

19.12.2010
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

19.12.2010
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

19.12.2010
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

19.12.2010
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.

23.11.2010
Regulation concerned clinical trial application forms, final reports and fees for submission each application form and application form for variation. ...