13/14 October 2020
On 3 June 2009 the EU Commission published the following statement: "Following the publication of the report on an impact assessment study by an external contractor DG Enterprise and Industry has taken the decision not to continue with the preparation of a Commission Directive on GMP for certain excipients as originally foreseen in Article 46(f) of Directive 2001/83/EC.
The results of a public consultation conducted by DG ENTR have confirmed concerns previously raised by stakeholders and experts from Member States regarding the lack of flexibility of the current legal basis, which stipulates for a list of certain excipients for which conditions of GMP should be applied and which should be established in implementing legislation.
The results of the consultation suggest a balanced approach for requiring GMP for excipients within the concert of legal requirements on manufacturing and quality control in the legal pharmaceutical framework. The requirement for selected GMP conditions to be applied for excipients seems to be justified both from a public health and a business perspective if linked to a formalised decision-making process by the manufacturer of the medicinal product. Such a decision making process should be based on the application of internationally agreed concepts and criteria for quality risk management (ICH Q9/ GMP Annex 20). An adjustment of the legal basis in Directive 2001/83/EC will be necessary for such a concept to be pursued further."
But what does this mean for the companies involved?
The manufacturer of the medicinal product would have to conduct risk assessment in order to define the appropriate GMP level. In May 2009 a meeting in Brussels organised by the EFCG informed the participants about the current status of a certification scheme which might fill the gap. What will be a challenge for the manufacturer of the medicinal product as well as for the excipient manufacturer is the classification of excipients into risk categories. With excipients classified, it is then necessary to define the required GMP standard. The procedure will be based on the existing IPEC-PQG GMP Guide. The higher classified excipients will be subject to a stricter application of the GMP principles.
There should be no doubt that excipients without any GMP control pose a risk to public health. Counterfeit or non-GMP-compliant excipients caused a number of tragic events with medicinal products in the recent past. As a result many people died, which raised the public awareness for the risks associated with non-controlled excipients. The decision of the EU Commission not to continue with the preparation of a Commission Directive on GMP for certain excipients possibly leads to a wrong and risky interpretation. Therefore the adjustment of the legal basis in Directive 2001/83/EC is urgently needed. A GMP standard defined by IPEC has been available for some time now. It was developed by the stakeholders involved and should be seen as the baseline of GMP for excipients.