The "primary reference (…) throughout the JSC procedure." 

🔊 On Dec 9th European Commission finally published 10 guidance documents for EU HTA. Even though publication of Implementing Acts attracted much more interest, the guidance documents are the fine print that will decide on the details. Today we will take a closer look at the procedures around JSC (G10).  Officially it is called "Procedural Guidance for Joint Scientific Consultations (JSC) on Medicinal Products (MP)". 

 

📋️ This is the procedure: 

1️⃣HTA secretariat will inform the HTD on selection of JSC request and detailed timetable of submission 

2️⃣"Day -30" (prior official start of JSC procedure): Submission of briefing package, using the official briefing template 

3️⃣HTA secretariat might request modifications of or further specifications to the briefing package 

4️⃣"Day 0" (= official start): Submission of amended briefing package 

5️⃣HTA secretariat will share briefing package with individual experts selected for this JSC 

6️⃣"Day 40": HTA secretariat will provide a "list of issues" LoI as preliminary feedback to HTD 

7️⃣Optional: Written feedback by HTD to LoI 

8️⃣"Day 60": Virtual discussion meeting between HTD, assessor and co-assessor, and individual experts 

9️⃣"Day 70": HTD to share minutes (in addition to the outcome document being prepared by assessor / co-assesor) - not officially endorsed 🤔 

 

❌ What's missing? 

🔹 Focus is on feedback to the development plan, not on the data requirements of the upcoming EU HTA 

🔹 Procedure of involvement of Member States not described 

 

🌰 In a nutshell: 

🔹 JSC for medicinal products is a good idea, but difficult to implement, given the boundaries by the HTAR. 

🔹 Even though the advice can be given in a parallel format together with EMA, these are still technically seperate processes with seperate outcomes, not one advice.