FOI release

Freedom of information pharmaceutical commitments

Case reference FOI2026/00180

Received 18 February 2026

Published 8 May 2026

Request

I am writing to request information regarding what formal commitments, obligations, and enforceable standards pharmaceutical companies are required to make, or are expected to meet, in order to bring an end to teratogenicity associated with medicinal products. For the purposes of this request, teratogenicity refers to preventable congenital, developmental, neurological, and lifelong harms arising from exposure to medicinal products before or during pregnancy, including where risks were known, foreseeable, or subsequently established. I respectfully request clarification on the following: 1. Commitments Required of Pharmaceutical Companies 1.1 What explicit commitments are pharmaceutical companies required to make to the MHRA to prevent, minimise, and ultimately eliminate teratogenic harm associated with their products? 1.2 Are companies required to commit to active prevention, rather than risk management alone, where teratogenic potential is identified? 1.3 What obligations exist to ensure that companies prioritise elimination of harm over commercial continuation of products with known teratogenic risk? 2. Pre-Clinical, Clinical, and Post-Marketing Responsibilities 2.1 What commitments must companies make regarding: • Robust pre-clinical reproductive and developmental toxicity testing • Transparent reporting of teratogenicity findings • Prompt action when safety signals emerge 2.2 Are pharmaceutical companies required to commit to continuous reassessment of teratogenic risk throughout a product’s lifecycle? 3. Transparency and Disclosure Commitments 3.1 What commitments do companies make to full transparency of teratogenicity data, including: • Pre-clinical and clinical study findings • Post-marketing surveillance data • Pregnancy exposure outcomes 3.2 Are companies required to provide plain-language information to patients and the public regarding teratogenic risks and prevention measures? 4. Accountability and Enforcement 4.1 What mechanisms does the MHRA have in place to ensure that commitments to end teratogenicity are: • Enforceable • Audited • Subject to sanction where breached 4.2 Are companies required to demonstrate learning from historical teratogenic harm and to implement measures to prevent recurrence? 5. Documentation Please provide copies or links to any: • Regulatory guidance • Codes of practice • Ethical frameworks • Enforcement policies that define or govern pharmaceutical company commitments to preventing and ending teratogenic harm. Thank you for your attention to this request. I look forward to your response in line with principles of transparency, patient safety, and public protection.

Response

See attached

Documents

• FOI2026_00180 (redacted).pdf (2.1 MB)

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