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HMA: Draft Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

30.10.2009
These Best Practice Guides are intended to facilitate the practical application of the guidance for the handling of Mutual Recognition variations outlined in Notice to Applicants, Volume IIA, ...

European Commission: Transatlantic Administrative Simplification Action Plan – 2009 implementation report

30.10.2009
Under the auspices of the Transatlantic Economic Council, on 28 November 2007 the European Commission hosted the Transatlantic Administrative Simplification Workshop which was co-chaired by the ...

MHRA: Over-the-counter cough and cold medicines: Guidance for the introduction of child resistant containers (CRCs)

30.10.2009
In February 2009, the Commission on Human Medicines (CHM) issued advice on over-the-counter cough and cold medicines for children. This included the advice that products containing the specified ...

FDA: SPL Standard for Content of Labeling Technical Qs & As

30.10.2009
This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup ...

EMEA: Guideline on Summary of Product Characteristics Rev.

23.10.2009
This guideline provides advice on the principles of presenting information in the SmPC. Applicants should maintain the integrity of each section of the document by only including information in ...

EMEA: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products in the treatment of depression with regard to treatment resistant depression

23.10.2009
There are new proposals with operationalized criteria for TRD available allowing definition of a patient population, which suffers from clinically relevant impairment and requires ...

EMEA: Concept paper on revision of Chapter 7 of the GMP Guide concerning \"outsourced GMP activities\"

23.10.2009
The guidance in Chapter 7 is high level and generally still applicable to these other outsourced GMP activities but was drafted at a time when the outsourcing of GMP activities was principally ...

MHRA: Three new publications have been added to the Labels, patient information leaflets and packaging for medicines section

23.10.2009
Two BROMI (Better regulation of medicines initiative) audit reports and Code of Practice for pack design for over-the-counter medicines have been added to the Labels, patient information leaflets ...

FDA: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

23.10.2009
This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR ...

EMEA: ICH Topic E7 Studies in Support of Special Populations

21.10.2009
ICH Topic E7 Studies in Support of Special Populations: Geriatrics - Questions and answers ...