NOVEMBER 26 – 27, 2015 IDMP TASK FORCE MEETING
by Susan Metz, Principal Consultant IDMP, PAREXEL International, and Member of the IDMP Task Force
On November 26– 27, 2015, the Substance & Product (S&P) subgroup of the IDMP Task Force, along with the EMA, the Referentials (R) subgroup and NCA representatives met in the EMA’s headquarters in Canary Wharf. Critical elements of the meeting may be found below, along with additional detail, including a likely EU timeline scenario. It is important to note that until the EMA posts their update to the IDMP website, the timelines provided herein, although considered the most likely path forward, are not official.
- The ISO working group responsible for the Product Implementation Guides (IG) are meeting the week of May 2nd 2016.
- The ISO group must decide if the current guides (TS20443 and TS20451) can be published or if they will need to go through a 2nd ballot
- Due to the hundreds of comments that need to be resolved, th.e general belief is that once the comments are addressed a 2nd ballot will be needed.
- If there is a 2nd ballot, the new target for the ISO IGs is 1Q 2017.
- The EU IGs will start to be drafted in the beginning of next year and will (must) use the ISO IGs as a base (which is the goal of standardization).
- The EU IGs can’t be finalized until after the ISO IGs are finalized. The new target for the EU IGs is 2Q 2017.
- The 92 fields that have been identified for EU Iteration 1 must be revisited because Industry has identified that some of the fields are not part of Article 57 and are also not needed for creating any of the IDs. The EMA will be reviewing these fields and determining if there is a business case for them to be included in Iteration 1.
- Industry proposed that they draft pieces of the EU IGs. The S&P group will work on how the guides might be split up to achieve having multiple people working on sections simultaneously.
- The EMA confirmed that submissions will start to be accepted 12 months after the EU IGs are published. Based on the new target, this would mean companies would start submitting 2Q 2018.
- The EMA also confirmed that six months later the submissions for Iteration 1 will be required – i.e. 4Q 2018.
- As part of the assessment for Iteration 1 data fields, there will be discussions between the EMA and Task Force about the possibility of adding what was being considered as Iteration 2, into Iteration 1.
- The goal is to have this list ready for the meeting occurring in February 2016.
- The Substance IGs are being progressed through the ISO process. Publishing of the EU Substance IGs are likely to be the same time as the Product IGs (2Q 2017). It’s expected that the majority of the EU Substance IG will have to do with the processes around Substance submissions.
- Substance implementation is needed prior to Product implementation. Regulators will be working on data for substances that are already authorized.
- Marketing Authorization Holders will need to be responsible for the data on new substances and specified substances.
- The S&P subgroup has been performing data pilots since the last task force meeting resulting in many questions based on their interpretation.
- The S&P subgroup will continue working on the pilot data with the EMA and Subject Matter Experts to resolve the questions prior to the February 2016 Task Force meeting.
- The EMA will provide industry with possible options for migrating XEVMPD data to IDMP.
- Industry had also done a mapping exercise and provided their input to the EMA to help with this exercise.
- It’s possible that industry may be asked to submit organization data in 2016/2017 because this data is needed for product submissions.
- This will be discussed at the next Task Force meeting.
- Many of the questions from the Referential subgroup were resolved, but there are still outstanding questions to be addressed.
- The current European Union Telematics Controlled Terms (EUTCT) system is targeted to be replaced by a new controlled terminology system and process by August 2016. This update is highly dependent on the work being done in the Referential subgroup.