EU-høring om god praksis for produksjon av og inspeksjonsmetoder for forsøksmedisiner

Tittel

(Under forberedelse) Delegert kommisjonsrettsakt om prinsipper og retningslinjer for god tilvirkningspraksis for forsøksmedisiner for mennesker og for kontrollrutiner, i henhold til første ledd i artikkel 63 (1) i forordning (EU) nr. 536/2014

(In preparation) Commission Delegated Act on Principles and guidelines on good manufacturing practice for investigational medicinal products for human use and inspection procedures, pursuant to the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014

Siste nytt

Åpen konsultasjon igangsatt av Kommisjonen 28.8.2015

Behandlende organ


 
 

Nærmere omtale

BAKGRUNN (fra Kommisjonens utkast til rettsakt, engelsk utgave)

INTRODUCION

Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC requires that the Commission adopt delegated acts to specify the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products.
Adherence to good manufacturing practice for investigational medicinal products for human use by manufacturers of such medicinal products is instrumental in ensuring the quality of the products which in turn will be an element in safeguarding the safety of the clinical trial subjects and in ensuring the reliability and robustness of the data generated in the trial.

Currently, Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use also sets out principles and guidelines for good manufacturing practice for investigational medicinal products for human use.

However, once Regulation (EU) No 536/2014 becomes applicable, manufacture and import of investigational medicinal products use in clinical trials carried out under that Regulation cannot follow the good manufacturing practice for investigational medicinal products for human use set out in Directive 2003/94/EC. Instead those investigational medicinal products have to be manufactured or imported under good manufacturing practice for investigational medicinal products for human use laid down by the Delegated Act provided for in Article 63(1) of Regulation (EU) No 536/2014.

The first subparagraph of Article 63(1) of Regulation (EU) No 536/2014 further provides that the Commission shall adopt Delegated Acts on the detailed arrangements for inspections.

As good manufacturing practice for investigational medicinal products for human use already exists and is generally well-functioning, there is no need to reinvent the wheel and therefore, this consultation document carries over the majority of the principles and guidance set out in Directive 2003/94/EC relating to investigational medicinal products for human use.

However, a new provision is proposed with regard to adaptation of good manufacturing practice for advanced therapy investigational medicinal products.

The topics of this consultation document concerning good manufacturing practice for investigational medicinal products for human use should be read in conjunction with the consultation on detailed Commission guidelines on principles of good manufacturing practice for investigation medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014, as that Commission guideline will supplement these Delegated Acts.

Article 63(4) of Regulation (EU) No 536/2014 puts an obligation on Member States to ensure compliance with good manufacturing practice for investigational medicinal products through inspections. For arrangements for inspections, inspiration for this consultation document is drawn from provisions on inspections of Directive 2001/83/EC and from already existing procedures (http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_proc...) agreed by the Member States.

With this public consultation, the Directorate-General for Health and Food Safety seeks the views of stakeholders regarding the content of such Delegated Acts.