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EMA: Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis

26.07.2011
New treatment options e.g. immunosuppressants prompt to reconsideration of treatment targets, target population, trial design, choice of endpoints, among others. In the dawn of treatments intended ...

Polish Ministry of Health: Regulation concerning on the amount and method of charging for the authorization to the manufacture of advanced therapy medicinal products.

26.07.2011
Regulation of the Polish Ministry of Health of 29.06.2011 concerning on the amount and method of charging for the authorization to the manufacture of advanced therapy medicinal products. ...

Polish Ministry of Health: Regulation concerning on specimen form of application for permission to the manufacture of advanced therapy medicinal products

26.07.2011
Regulation of the Polish Ministry of Health of 29.07.2011 concerning on specimen form of application for permission to the manufacture of advanced therapy medicinal products. ...

GMP: New: ICH Guideline for ICH Q8, Q9 and Q10 implementation

26.07.2011
On 16 June 2011 the International Conference on Harmonisation (ICH) Quality Implementation Working Group published a new document entitled: \"POINTS TO CONSIDER ICH-Endorsed Guide for ICH ...

Polish Registration Office: Communication of the President of Registration Office on the implementation of the principles of post authorization changes.

26.07.2011
In connection with the Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and ...

EMA: Guideline on stability testing for applications for variations to a marketing authorization

26.07.2011
The following guideline provides guidance on the stability data which have to be generated in order to support a variation to a Marketing Authorisation. The guideline provides general guidance on ...

EMA: Concept paper on the need for revision of the Guideline on non-clinical local tolerance testing of medicinal products (CPMP/SWP/2145/00).

26.07.2011
The existing guideline on local tolerance is dated 1 March 2001 (1). Over the past years, newer routes of administration, e.g. transdermal systems, are being used more frequently and a shift has ...

GMP: EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use

20.07.2011
The Guidelines laid down in Article 84 of Directive 2001/83/EG on Good Distribution Practice (Document 94/C 63/03) haven\'t been changed since their first publication in the Official Journal of ...

EMA: Guidance for companies seeking scientific support and advice on traditional herbal medicinal products

20.07.2011
The following guidance has been established for companies who may want to seek scientific support and advice from the Committee on Herbal Medicinal Products (HMPC) on traditional herbal medicinal ...

GMP: FDA publishes Draft Guidance on Classification of Products as Drugs or Devices

13.07.2011
Based on the number of requests from manufacturers addressed to the Agency concerning the classification of their products as a drug or a device, the FDA published a new guidance which should help ...