ABPI news

Recently there has recently been a flurry of consultative activity by the European Commission on various GMP topics. Mention has previously been made in this column of the provisions of the EU directive 2004/27/EC, which amended the EU medicines legislation and introduced a requirement for active pharmaceutical ingredients (APIs) to be manufactured in accordance with GMP.

In March the European Commission issued consultation papers setting out proposals for implementing this requirement. The responsibility for ensuring compliance lies with the manufacturer's authorisation holder for the medicinal product, but also empowers the competent authorities of member states to inspect API manufacturers where they deem it appropriate. The consultations (available at http://pharmacos.eudra.org/F2/pharmacos/new.htm ) set out draft guidance on when it is appropriate for member states' competent authorities to exercise that power. The commission also sought comments on proposed amendments to annex 18 of the EU GMP guide, which relates to the manufacture of APIs. These proposals make changes to the introductory section of that annex, although the remainder of the guidance is not affected.

Separate consultations were also released by the EC on the formats of the manufacturer's authorisation for the manufacture of medicinal products, and on the certificate of GMP compliance for a manufacturer.

The timescale for comments on these consultations was very short (4 April). ABPI submitted comments on the consultations. The degree to which the proposals are amended by the commission in the light of comments received remains to be seen, but the publications at least give the essence of their thinking in this area.

As the implementation date for these provisions of 30 October draws closer, there will be increasing debate on the requirements and how manufacturers can fulfil their duties under the legislation.