NorthWest Biotherapeutics Inc (NWBO)

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Senti, how do you square your theory of immediate validation upon submission, with the MHRA stating their goal is to validate within two weeks?

Euro Roundup: MHRA misses performance targets amid resource constraints, Brexit backlogs
Roundups
Roundups
| 21 July 2022 |
Nick Paul Taylor

Euro Roundup: MHRA misses performance targets amid resource constraints, Brexit backlogs
The UK Medicines and Healthcare products Regulatory Agency (MHRA) missed multiple performance targets for its 2021-2022 financial year due to resource constraints, Brexit backlogs, and additional reasons.

MHRA started the financial year aiming to produce 97% of validation reports for new marketing authorization applications within 14 days of case creation; instead, the agency achieved the 14-day target 83.4% of the time.

“Embedding centrally authorized products (CAP) grandfathering transition activities resulted in backlogs in Q1 and a missed target,” MHRA wrote in its report. CAP grandfathering refers to the conversion of all existing EU marketing authorizations to British authorizations because of Brexit. MHRA cited the same pressures as a reason why it missed the target in its 2020-2021 financial year.

With the backlog cleared, MHRA said “performance was recovered” in the second quarter and “returned to target” in the second half of the year

MHRA is looking to its new organizational structure to improve performance against other targets, such as the 80-day goal of assessing applications to market new active substances 97% of the time.

For your assistance: Bard’s definition of validation report.

A Marketing Authorisation Application (MAA) Validation Report for a single drug application is a document issued by a regulatory agency after assessing the completeness and administrative acceptability of an MAA submission. It essentially confirms that the application includes all the necessary information and documentation required for further scientific evaluation.

Here's what an MAA Validation Report for a single drug application typically includes:

1. Case Information:

Date of application submission
Application number
Applicant name and contact details
Drug product name and proposed trade name(s)
Active pharmaceutical ingredient(s)
Dosage form and strength
Therapeutic indication(s)
2. Administrative Assessment:

Confirmation of payment of required fees
Review of the electronic submission format and compliance with eCTD specifications
Assessment of the presence of mandatory modules and sections within the eCTD structure
Identification of any missing or incomplete documentation
Verification of the validity of relevant certificates and licenses
3. Outcome:

A clear statement indicating whether the application is administratively validated or not.
If not validated, a list of deficiencies that need to be addressed before further evaluation can proceed.
If validated, a timeline for the start of the scientific assessment.
4. Additional Information:

Information on how to address any discrepancies or missing information.
Contact details for the agency responsible for further assessment.
Links to relevant guidance documents and regulations.
It's important to note that the specific content and format of an MAA Validation Report may vary depending on the regulatory agency involved and the applicable regulations. Therefore, it's always recommended to consult the agency's guidance documents and specific requirements before submitting an MAA.