News
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
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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
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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
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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
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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
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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) ...
EMA: Scientific guideline: Guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.
23.11.2010
This guideline contains guidance relating to the data to be provided in support of a request for the CVMP to consider the inclusion of an excipient in the list of substances considered as not
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European Commission: Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Chapter 5: Production.
23.11.2010
Reasons for changes: changes have been proposed to sections 25 and 26 on the qualification
of suppliers of starting material in order to reflect the legal obligation of
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EMA: Scientific guideline: Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products
15.11.2010
This reflection paper addresses the need for specific requirements for establishing the stability of herbal medicinal products (HMPs). The quality, including the stability, of HMPs should be
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