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Regulatory Affairs Newsletter Archive

Just Released: CLSI NBS11: Guidance for Newborn Screening of Congenital Adrenal Hyperplasia Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Just Released: CLSI NBS11: Guidance for Newborn Screening of Congenital Adrenal Hyperplasia

The new CLSI NBS11 - Newborn Screening for Congenital Adrenal Hyperplasia, provides laboratories with clear recommendations for using dried blood spot specimens to perform newborn screening (NBS) for congenital adrenal hyperplasia (CAH). This newly released standard covers the full testing process, including preanalytical, analytical, and postanalytical phases, as well as both short-term and long-term follow-up considerations.  
Ben Kemp
August 21, 2025
MHRA – Announcing our Route B substantial modification pilot Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA – Announcing our Route B substantial modification pilot

Although the below update is specific to drug trials it includes information of when sponsors need to make Change notifications/submissions which includes when there are changes to technical equipment used during the trial, or when there are changes to diagnostics used to monitor the trial. Join our Route B substantial modification pilot  A Route B substantial modification refers to a…
Ben Kemp
August 21, 2025
Biocides: Upcoming EU active substance open invitation deadline Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming EU active substance open invitation deadline

Upcoming EU active substance renewal submission deadline Apply for active substance renewal by the deadline to keep products on the NI market. 27 August 2026 Citric acid (CAS 77-92-9 EC 201-069-1) in product type 2
Ben Kemp
August 21, 2025
CLP: Publication of GB MCL Agency Opinions Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

CLP: Publication of GB MCL Agency Opinions

Publication of GB mandatory classification and labelling (GB MCL) Agency Opinions The next batch of GB MCL Agency Opinions are now available for download. A GB MCL Agency Opinion formally proposes the GB MCL for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with an assessment of…
Ben Kemp
August 21, 2025
DSIT Updates (WC 18 August) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 18 August)

UK Business Data Survey 2026: User-engagement exercise Page summary: The Department for Science, Innovation and Technology (DSIT) is seeking views from users of the UK Business Data Survey (UKBDS) on how it could be developed. Change made: Outcome of the user engagement exercise has been published. Time updated: 10:05am, 11 August 2025 Adoption of cyber insurance by UK small and…
Ben Kemp
August 21, 2025
DEFRA Updates (WC 18 August) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 18 August)

Sustainable procurement: the Government Buying Standards (GBS) Page summary: GBS product specifications: mandatory for central government departments and related organisations; encouraged for wider public sector. Change made: Added information about a stakeholder survey to help shape updates to the Government Buying Standards. Time updated: 12:01am, 11 August 2025 Imports, exports and EU trade of animals and animal products: topical issues…
Ben Kemp
August 21, 2025
Department for Business and Trade Updates (WC 18 August) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 18 August)

British investment boost in Ukraine to benefit both countries Page summary: British investment boost in Ukraine to support security and prosperity of both countries. Change made: Background section has been updated to include further information published by the Government of Ukraine. Time updated: 4:24pm, 11 August 2025 Business to consumer (B2C) and business to business (B2B) EEE and WEEE: how…
Ben Kemp
August 21, 2025