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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. ...

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

23.11.2010
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 ...

EMA: Regulatory and procedural guideline: Concept paper on Storage Conditions during Transport, draft.

23.11.2010
The globalisation of the manufacture of human and veterinary medicinal products has brought both benefits and a wide range of challenges. This paper is concerned with challenges related to ...

EMA: Dossier requirements of the members of the Committee for Medicinal Products for Human Use (CHMP)

23.11.2010
Dossier requirements and personal data of the members of the Committee for Medicinal Products for Human Use (CHMP) ...

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