Upcoming legislative changes

Question 1

What are the proposed updates to 2001/83/EC?

What are the proposed updates to 726/2004?

Answer 1

2001/83/EC- Total overhaul to consider patient unmet needs, Innovative industry support and Resilience to crisis.

726/2004- Human medicine regulation in EU. Proposed creation of a regulation to cover the inclusion of paediatric medicines.

Creation of new directive- De-centralised manufacture/testing- central hub has MIA and QPs.

Question 2

What are the proposed changes for QP duties put forward in the new EU human medicines directive?

Answer 2

Decentralised manufacture- QP and MIA at central site.

1. Confirm GMP at each site
2. Written confirmation of GMP compliance
3. Provide information to NCAs on location and changes of activity at decentralised sites.
4. New Legal duty- MA holder and QP ensure practical experience acquired is appropriate to the types of products to be certified.

Question 3

What is the ICH approval procedure?

Answer 3

Step 1- Consensus on technical document
Step 2a- Confirmation of technical document
Step 2b- Adoption of draft guideline
Step 3- Review of draft guideline
Step 4- Adoption of harmonised guideline
Step 5- Implement (with or without Q+A)

Question 4

What are recent ICH updates?

Answer 4

ICH M7 mutagenic impurities;
-Compound specific acceptable intakes.
-API synthetic route changes
-Changes in manufacture/formulation/composition
-Changes in dosing regime

New ICH Q13- continuous manufacture chapter
- Needed as required to cover new technology, efficient manufacturing, key scientific and regulatory concepts.
-Drug product and drug substance
-Biotech and chemical

ICH Q2 and ICHQ14;
ICHQ2- Knowledge from procedure development (ICH Q14-Analytical Target Profile) can inform validation requirements, Clear validation parameter guidance, Examples for analytical techniques.

ICHQ14- Quality by design of method, analytical target profile (ICHQ8), Product lifecycle management detail from ICHQ12

Question 5

What are proposed changes to UK legislation?

Answer 5

Medicines and medical devices act 2021 (can outline new SIs)

Point of care manufacturing (Decentralised manufacture)

Simplified CT regulations- Combined ethics and regulatory review, trial lapse in 2 years, Notification scheme for low impact trials.

UK medicines verification system