EMA publishes reflection paper on GMP and MA Holders

The European Medicines Agency has recently published a 29 page Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation holders (MAHs).

Whilst it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) Guide to GMP (the ‘GMP Guide’) refers in several places, to MAHs and their responsibilities in relation to GMP.

Generally, these responsibilities range from those that relate to outsourcing and technical agreements, to ones that require the MAH to perform certain specific tasks e.g. evaluating the results of product quality reviews, agreeing irradiation cycles with manufacturers, etc.

The GMP Guide states: “…the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder”. A significant part of the performance of a medicinal product relates to compliance with the GMP requirements during product manufacturing.

Why has the refection paper been published?

The MAH responsibilities stated in the GMP guide are spread over various chapters and annexes of the Guide and are quite numerous. There are also various GMP-related responsibilities for MAHs stated in applicable medicines legislation.

However, there appears to be a lack of clarity and understanding about what these responsibilities actually and what they mean for MAHs, especially at a practical level. It would therefore be beneficial to MAHs (as well as to manufacturers, GMP Inspectors and other stakeholders) if these responsibilities were documented in one place and adequately explained. The Reflection Paper seeks to address this task.

How does the Reflection Paper set out the various MAH Responsibilities?
  • In Section 5 of the paper, each GMP requirement that applies to the MAH is outlined, with its key message stated or summarised.
  • This is then followed by the exact text that is in the GMP Guide (or in applicable legislation or in other guidelines) on this point. In some cases, the exact text is presented between quotation marks.
  • A clear reference to the relevant part of the GMP Guide or the applicable legislation is then stated.
  • Where possible, an explanation of what the requirement means at a practical level for the MAH is provided, in italics.

Overall, this Reflection Paper is intended to be of assistance to MAHs as they work with the product manufacturers and other stakeholders to facilitate compliance of the medicines placed on the market, in terms of GMP and the Marketing Authorisation. This ultimately serves the interests of patients as it contributes to ensuring the availability of high quality, safe and effective medicines.

Source: Europa Website