What's new details

Question 1

Re CTR, what’s the new word for amendment

Answer 1

modification

Question 2

Describe CTR notification scheme?

Answer 2

MHRA will auto-approve the trial in 14 days if meets the criteria.

Typically lower risk - phase 3 and 4

Question 3

When do trial approvals lapse?

Answer 3

2 years after approval of the trial if no participants IN THE UK

Question 4

What are the main points with the new clinical trials regulations

Answer 4

• Combined Review:
  Ethics and regulatory approval in a single application.
• Notification Scheme:
  A notification scheme for lower-risk clinical trials is introduced, meaning some trials will only require notification rather than full approval by the MHRA.
• Faster Approvals:
  The goal is to reduce the time it takes from 250 to 150 days from application

2. Enhanced Transparency:
   * Public Registration:
   Clinical trials will be legally required to be registered in a publicly accessible registry.
   * Result Publication:
   Trial results must be published within 12 months of the trial’s conclusion, with the possibility of deferral for commercially confidential information.
   * Participant Summary:
   Trial sponsors must offer participants a summary of the results in an easily understandable format.
   * Longer Trial Master File Retention:
   The regulations extend the requirement for archiving trial master files to 25 years.

Question 5

What is the SI for new CTR?

Answer 5

2025/538

Question 6

What’s the new SI amending 2012/1916 for MM & POC

Answer 6

2025/87

Question 7

What is decentralised manufacturing?

Answer 7

decentralised manufacturing (DM) refers to the production of medicinal products at or near the point of patient care, rather than at a single, centralised manufacturing facility

Question 8

How does decentralised manufacturing affect standard centralised manufacturing

Answer 8

Supposed to complement it alongside standard manufacturing

Question 9

When does 2025/87 come into effect?

Answer 9

23 Jul 25

Question 10

What is the name of 2025/87

Answer 10

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025

Question 11

What are the key points about the new modular manufacture and point of care regulations?

Answer 11

Introduce point of care and modular concepts

Point of care = short shelf life at hospital / theatre even. Can only be manufactured locally (e.g. preparing a filling at a dentist)

Modular = not at point of care but decentralised for reasons relating to deployment. - synchronise product and patient or early pandemic

Needs to be justified

Need a DM MF - drug manufacturing master file for each product

Need a control site - the hub with the QP and MIA and on MA

Question 12

How do you manage changing site of manufacture with POC or MM product

Answer 12

No variation to change site of manufacture as managed by DM MF

Question 13

What’s in a DM MF

Answer 13

Process and Product

Process
Sites
Process for onboarding or getting rid of sites
Supervision details
Reporting adverse events process

Product
Follows CTD
Product and method of manufacture
Control strategy - CQAs, CPPs,
Process Validation
Comparibility protocols

Question 14

What are the key attributes of DM MF

Answer 14

One product only - not generic

Live doc kept up to date

Annual reporting of updates and changes needed

Question 15

Does decentralised procedure apply to CT?

Answer 15

Yes but need to be really careful about blinding