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European Commission: New regulation on Maximum Residue Limits has entered into force

27.07.2009
The new Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation ...

MHRA: New reclassifications of medicines

27.07.2009
A brief summary of reclassifications that have been approved in the past 12 months. ...

MHRA: Marketing Authorisation applications for medicines using the Decentralised procedure (DCP) with the UK as Reference Member State (RMS): New or earlier slots available in all therapeutic areas

27.07.2009
As a result of cancellations and delays in submissions for booked DCP slots, MHRA has some capacity in all therapeutic areas to offer new or earlier slots to applicants for procedures commencing ...

MHRA: Adverse drug reaction (ADR) reports received by the MHRA from literature articles

27.07.2009
This section provides a list of UK spontaneous adverse drug reaction (ADR) reports based on articles from the scientific literature. The list is updated daily and provides the MHRA ADR reference ...

Polish Ministry of Health: The project of Act of the Pharmaceutical law

23.07.2009
Polish Ministry of Health published the amendment of Act of the Pharmaceutical law. Comments for this act can be apply till 18 of August. ...

EDQM: Actions taken by the EDQM.

22.07.2009
The EDQM announces the suspension of the following CEPs. ...

FDA: ANDAs: Impurities in Drug Substances

16.07.2009
Food and Drug Administration (FDA) published Guidance for Industry which provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the ...

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

16.07.2009
Food and Drug Administration (FDA) published draft Guidance, which provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. ...

FDA: Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

14.07.2009
Draft guidance - comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the ...

EMEA: Note for Guidance on Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions

13.07.2009
International Committee for Harmonization guidance has been published - ICH Topic E16, Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions. ...