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Regulatory and Governance News

06 November 2008

Model Clinical Investigation Agreement (mCIA) launched today

05 November 2008

NIHR Coordinated System for gaining NHS Permissions - important changes for researchers from 18 November

First Stage of NRES Research Summary Database Underway

New declaration of Helsinki

UKCRC Regulatory & Governance Advice Service

UKCRC Registered Clinical Trials Units website launched

MHRA publishes a response to MLX 350, its consultation on Amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements

Approval of research involving ionising radiation

News from Patient Information Advisory Group (PIAG)

New guidelines on the application of certain aspects of the Orphan Medicines Regulation published

EudraLex Volume 9A of The Rules Governing Medicinal Products in the European Union – September 2008 published

Medicines regulators on both sides of the Atlantic confirm commitment to cooperation on medicines

Update on the Human Fertilisation and Embryology Bill

20 October 2008

DH Guidance note: Security of NHS patient data shared for research purposes

Launch of procedure for investigating research misconduct

Reminders to REC applicants

NHS European Office

The Medicines for Healthcare products Regulatory Agency (MHRA) release a new web resource about medicines

The Human Tissue Authority (HTA) launches five summary inspection reports

UK Clinical Research Network (UKCRN) launch a new project to implement the HR Good Practice Resource Pack

02 September 2008

Medicines and Healthcare products Regulatory Agency (MHRA) to review and consolidate medicines legislation

Guidance on the Medicines and Healthcare products Regulatory Agency’s (MHRA) handling of the requirement in the Paediatric Regulation to undertake a ‘compliance check’ during validation

Notification of the use of a non-good laboratory practice (GLP) compliant facility form updated

Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling

Concept paper on the dvelopment of a guideline on pharmaceutical development of medicines for paediatric use

New regulatory and procedural guidance section on the European Medicines Agency (EMEA) website

Security of NHS patient data shared for research purposes

Manufacturers, companies and hospitals having advanced therapy medicinal products legally on the market in the European Union are reminded of the need to contact the EMEA regarding authorisation of these products

Changing the name of a company for authorisations held under Medicines Regulations