New EU GMP Guideline for IMPs

In relation with the new EU GCP Regulation 536/2014, the EU Commission published its new GMP guideline on investigational medicinal products (IMPs) for human use on 16 September 2017. The EU GMP guidelines on investigational medicinal products are currently included in Annex 13 of the EU GMP Guideline.

As reported before, the EU commission conducted a public consultation in 2015, where stakeholders could comment on whether the regulations regarding the GMP guidelines for medicinal products for human use and investigational medicinal products should be divided. As a result of the consultation, the EU Commission now published two documents in the Official Journal of the European Union:

  • Directive 2017/1572 on principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use to supplement Directive 2001/83/EG (for advanced therapy medicinal products (ATMPs), the guidelines of Article 5 of EG regulation 1394/2007 apply);
  • Delegated Regulation 2017/1569 for specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections.

Both subsections are currently part of Directive 2003/94 (8 October 2003) for determining the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. According to Article 15 of the new GMP Directive on medicinal products for human use 2017/1572, Directive 2003/94 is then to be suspended (see below).

GMP meets GCP:

Article 12 of the Delegated Regulation 2017/1569 (GMP) also regulates the responsibilities of Qualified Persons (QPs) in context with the EU GCP Regulation 536/2014 (EU-GCP-Reg.):

  • For IMPs manufactured in the member state concerned, a QP verifies that each batch has been manufactured and checked in compliance with the GMP requirements for investigational medicinal products laid down in Regulation 2017/1569 and the information pursuant to Article 25 of the EU-GCP-Reg.;
  • For IMPs manufactured in a third country, the QP verifies that each batch has been manufactured and checked in accordance with quality standards at least equivalent to those laid down in this GMP-Regulation and the information pursuant to Article 25 of the EU-GCP-Reg. taking into account the guidelines referred to in Article 63(1) of the EU-GCP-Reg. on manufacturing and import;
  • The qualified person shall certify in a register or equivalent document provided for that purpose that each production batch complies with the requirements mentioned above. The register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the competent authority for at least five years after the completion of or the formal discontinuation of the last clinical trial in which the product batch was used.

CHAPTER III of the Delegated GMP Regulation 2017/1569 regulates INSPECTIONS, also in accordance with the EU-GCP-Reg.:
By means of regular GCP inspections as referred to in Article 63(4) of the EU-GCP-Reg. the Member State shall ensure that holders of an authorization as referred to in Article 61(1) of that Regulation comply with the principles of GMP laid down in this Regulation (2017/1569) and takes into account the guidelines referred in second subparagraph of Article 63(1) of the EU-GCP-Reg..

Regarding the date of entry into force, both GMP documents relate to the initial application of the EU-GCP-Regulation 536/2014 (according to the EMA, this will be in 2019; an exact date is supposed to be set in October 2017):

  • Directive 2003/94/EG will be suspended with the initial application of the EU-GCP-Reg. or as of April 1, 2018, whichever date is later. References to the repealed Directive shall be construed as references to Directive 2017/1572 and to Delegated Regulation 2017/1569 and read in accordance with the correlation table in the Annex of Directive 2017/1572.
  • Since Directive 2017/1572 has to be converted into national law, Article 16 of this Directive asks member states to adopt and publish, until March 31, 2018, at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive
  • Directive 2017/1572 and Delegated Regulation 2017/1569 shall enter into force on the twentieth day following that of their publication (i.e. on October 6, 2017). They shall apply from the date of applicability of the EU-GCP-Reg. or as of April 1, 2018, whichever date is later.

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