EMA and EU Commission – Topical News

Rubrik: europharm

(Treffer aus pharmind, Nr. 11, Seite 1761 (2013))

Röhrig-Friese B

EMA and EU Commission – Topical News / Paediatric Investigation Plan – Public Consultation on the Revision of the Guideline on Format and Content of Applications for Paediatric Investigation Plans · Röhrig-Friese B · Rechtsanwaltskanzlei Röhrig-Friese, Betzdorf/Sieg (Germany)
Since 26 January 2007, the new Paediatric Regulation No. 1901/2006 on medicinal products for paediatric use has been in force. As in any other important legislative act, the setting up of the guidance documents is imposed on the European Commission. Based on the general report on the experience required under the application of the regulation from June 2013 the EMA and the Paediatric Committee elaborated a proposal for a revised “Guideline on the format and content of applications for paediatric investigation plans” amending the original guideline in force since September 2008.

EMA and EU Commission – Topical News

Rubrik: europharm

(Treffer aus pharmind, Nr. 09, Seite 1438 (2013))

Röhrig-Friese B

EMA and EU Commission – Topical News / Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use – Public Consultation on the Revision of Annex 16 on the Certification by a Qualified Person and Batch Release · Röhrig-Friese B · Rechtsanwaltskanzlei Röhrig-Friese, Betzdorf/Sieg (Germany)
According to Art. 46 (f) of Directive 2001/83/EC (Human Code) the holder of the manufacturing authorisation is responsible for compliance of manufacture of medicinal products with GMP-principles and provisions of the marketing authorisation dossier and is required to have at least one Qualified Person (QP) at its disposal. Due to remarkable amendments which have been made to Title IV of the Human code relating to manufacture and importation by Directive 2011/62/EC on Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products, the Commission is continuously updating its Guidance to adapt it to the new requirements. Actually, a ...

EMA and EU Commission – Topical News

Rubrik: europharm

(Treffer aus pharmind, Nr. 09, Seite 1462 (2012))

Röhrig-Friese B

EMA and EU Commission – Topical News / Proposal of a Regulation on Clinical Trials of the European Parliament and the Council, repealing the Clinical Trial Directive 2001/20/EC – Part I – Overview · Röhrig-Friese B · Rechtsanwaltskanzlei Röhrig-Friese, Betzdorf/Sieg (Germany)
Since 2001, the provisions on Good Clinical Practice are laid down in Directive 2001/20/EC (OJ No. L 121, 1.5.2001, p. 34 ff). Now a new proposal for a Regulation on clinical trials has been presented, which revises the legislative framework for clinical trials in Europe. In the assessment following the Commission Communication of 10 December 2008 on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector” the provisions of Directive 2001/20/EC had been identified as one of the most critical aspects of European pharmaceutical law, having led to a huge increase of costs for clinical trials for all ...