Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems. Outcome of 10 September 2012 Workshop

Transcription

1 Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems Outcome of 10 September 2012 Workshop Management Board Meeting - Agenda Point B10 04 October 2012 Presented by: Noël Wathion Head of Unit, Patient Health Protection An agency of the European Union

2 Scope (1/3) Meeting with European Commission and National Competent Authorities representatives as agreed at the June 2012 HMA meeting Discussion focused on Reflection Paper and Implementation Plan Implementation of Article 46 of the Falsified Medicines Legislation 1

3 Scope (2/3) Discussion on the Reflection Paper and Implementation Plan covered the following topics Best use of the regulatory framework Clinical perspective Perspective from a NCA Inspection and compliance perspective Communication aspects 2

4 Scope (3/3) Discussion on Article 46 covered the following issues Update from the European Commission on initiatives taken Presentation of the EMA risk analysis methodology for centrally authorised products 3

5 Outcome Discussion on Reflection Paper/ Implementation Plan (1/3) Agreement to include the following additional actions in the Reflection Paper/Implementation Plan Develop a common understanding of the concept of essential medicine for subsequent application at national level Develop a decision tree to assist NCAs in deciding what shortages should be dealt with at EU level 4

6 Outcome Discussion on Reflection Paper/ Implementation Plan (2/3) Agreement to include the following additional actions in the Reflection Paper/Implementation Plan (cont d) Provide clarification on how to best provide national input into the development of EU advice/communication and how such EU advice/ communication and national advice/communication can be complementary When revising the current quality defect procedure (as already proposed) ensure that such revision will not result in non-urgent information being transmitted 5

7 Outcome Discussion on Reflection Paper/ Implementation Plan (3/3) Agreement to include the following additional actions in the Reflection Paper/Implementation Plan (cont d) Undertake a survey of past initiatives taken by NCAs to manage/prevent shortages in order to develop an inventory of possible tools available to NCAs and to share best practice (action: European Commission) For the other actions it was agreed to establish a virtual group (EMA, Italy, Poland, Spain, UK) to further develop these actions Link to the EU Incident Management Plan was supported as well as the role of the Incident Review Network 6

8 Outcome Discussion on Article 46 (1/4) First information was provided by the European Commission on the initiatives taken by the Commission in terms of discussions with Regulatory Authorities (India, China, Brazil, US, Singapore, Canada, Switzerland, Australia), raising awareness with other concerned parties, publication of guidance, discussion with PIC/s to help with additional training, assessment of the equivalency of WHO GMP to EU European Commission has asked EMA to prepare a methodology for risk analysis for CAPs and to share this methodology with the Member States 7

9 Outcome Discussion on Article 46 (2/4) Methodology for risk analysis was presented by EMA; it consists of the following steps Step 1: initial screening of the CAPs: 50 CAPs clearly at risk, 150 CAPs potentially at risk Step 2: detailed analysis of CAPs potentially/clearly at risk leading to a list of active substance manufacturing sites in 3 rd countries ranked by risk category Step 3: critical analysis of sites in highest risk category from step 2 (requires information from MAHs) will allow for a prioritisation Step 4: involve clinical experts (CHMP) in the risk analysis to take into consideration the clinical relevance of the CAP in case of shortage and the availability of alternative products 8

10 Outcome Discussion on Article 46 (3/4) EMA methodology was welcomed by the Workshop participants EMA methodology will be shared with the Members States (already done) It is anticipated that an equivalent analysis of NAPs is likely to reveal several thousands of products at risk 9

11 Outcome Discussion on Article 46 (4/4) The need to raise awareness at the level of the MAHs was emphasised Whilst acknowledging the European Commission s initiatives participants felt that further reflection is needed on appropriate contingency measures and the need for, and content of, communication on shortages resulting from the implementation of Article 46 10

12 The Board Is Invited To adopt the revised Reflection Paper and Implementation Plan To consider the outcome of the discussions on the implementation of Article 46 and the need for additional actions 11