The GMP/GDP consultative committee met recently on the 18 April 2016 at the MHRA offices in Buckingham Palace Road, London. The attending bodies consisted of quality associations, Industry associations and professional organisations. Among the many interesting topics discussed were the topical subjects of data integrity and harmonisation.
The consensus/proposal moving forward is that data integrity should not be seen as just a GMP issue or requirement. There has always been a need to ensure that good quality data is at the foundation of any medical or clinical decision where the safety of patients or participants is always paramount. The MHRA are themselves close to issuing a GxP wide guidance document on data integrity which will be interesting to read and understand. It is understood that it will extend these principles into both Good Clinical and Laboratory Practices. So we anticipate the circulation of the guidance and encourage all interested and involved parties to make comments in the near future.
The World Health Organisation (WHO) are also producing a GxP wide guidance document which is close to publication. As the MHRA co-chairs the PIC/S working group on data integrity and this group is looking to publish guidance harmonised across all PIC/S members (Pharmaceutical Inspection and Cooperation Scheme) and it is hoped that this will help secure a unified approach to data integrity.
Harmonisation also came up in discussion in the shape of the Mutual Reliance Initiative (MRI). The MRI is a strategic collaboration between EU regulatory authorities and the US-FDA to evaluate whether we have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines so that we can rely on each other’s information. The EMA and Commission are visiting the FDA this week as part of the MRI discussions, with the scope of any agreement still under discussion it unlikely that we may see anything concrete in the near term.
This does parallel somewhat with the Transatlantic Trade and Investment Partnership (TTIP) discussions ongoing between Europe and the USA. In May 2016 the EU issued a document proposing an annex to cover medicinal products covered by a marketing authorisation in the EU which would in essence lead to regulatory inspection certificates from national authorities being accepted by the FDA and theoretically end routine FDA inspections of EU manufacturing sites. A perfect point at which to say watch this space, however, it is anticipated that this will not be an overnight sensation and will take considerable time. The TTIP negations are mired in challenges and some controversy. Much information is available from the European Commission website under trade amongst many others. Worth a look.
However, the elephant in the room is the upcoming UK referendum on membership of the EU. Should the UK “Brexit” where we would stand in relation to this going forward, is the question on everyone’s lips!