Jurisdiction(s):
United Kingdom

Key definition

Accelerated assessment definition

What does Accelerated assessment mean? A fast‑track regulatory review route used in medicines licensing to shorten the time regulators take to evaluate a marketing authorisation (MA) application. It is not a statutory term of art; its operation is set by medicines regulators through procedure and guidance. EU (including Ireland): under European Medicines agency (EMA) procedure, the CHMP may grant accelerated assessment where a medicinal product is of major public‑health interest and represents therapeutic innovation. The active evaluation time is reduced from 210 to 150 days (clock‑stops for applicant responses still apply). Standards of evidence are unchanged and the CHMP may revert to the...

UK and EU Life Sciences Regulatory Glossary (A–B) for Lawyers: Medicines, Medical Devices, ATMPs, Biosimilars and AI

Published by a LexisNexis Life Sciences expert

Practice notes

C–D | E–H | I–N | O–P | Q–V.

accelerated assessment

Many countries provide a regulatory route that speeds up the appraisal of certain medicinal products, helping them reach patients sooner. In the EU, this accelerated assessment significantly shortens the period for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to examine a marketing authorisation (MA) application from 210 to 150 evaluation days overall. An application can be considered for this pathway where the CHMP judges the product to be of major relevance for public health and therapeutic innovation. See Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products—EU centralised authorisation procedure. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) provides a 150-day review for all high‑quality new MA applications to hasten equitable access to new medicines for UK patients. The MHRA assesses applications for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and delivers its considered view on whether to grant a licence for new medicines promptly within 150 days of the receipt of a valid application. See Practice Note: UK marketing authorisations for medicinal products—Accelerated assessment route (150-day)—UK routes...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Web page updated on 22/05/2026

Popular documents

Using the Judicial College Guidelines to assess general damages in personal injury claims

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...