FOI release
FOI commitment to transparency on teratogenicity
Case reference FOI2026/00178
Received 18 February 2026
Published 8 May 2026
Request
. MHRA’s Commitments to Transparency on Teratogenicity Please provide explicit information on the MHRA’s policies, standards, and current or planned commitments in the following areas: 1.1 Regulatory Communication of Teratogenic Risks • How the MHRA identifies, assesses, and communicates teratogenic risks associated with medicines. • Whether and how risk assessments of potential teratogenic effects (including pre-clinical and clinical evidence) are communicated to healthcare professionals, patients, and the public, including timelines. 1.2 Publication of Safety Information • How and when the MHRA publishes safety signals and assessments related to teratogenicity (e.g., emerging evidence from post-marketing surveillance, safety reviews). • What public registries, safety update reports, or risk communications the MHRA uses to ensure this information is accessible. 1.3 Evidence Summaries and Decision Rationales • Whether MHRA publishes plain-language summaries or detailed rationales explaining how decisions involving teratogenic risk were reached (e.g., product labeling changes, contraindications, pregnancy warnings). • If such summaries exist, the timelines within which they are made available following decision points. 1.4 Patient and Public Engagement • How the MHRA engages with patients, advocacy groups, health professionals, and the public to inform them about the potential teratogenic risks of medicines. • Whether there are mechanisms for patient feedback or involvement in regulatory communications specific to teratogenic risk. • How does the MHRA choose members of any teratogenic stakeholder groups within the MHRA 1.5 Confidentiality vs Public Interest • How the MHRA balances commercial confidentiality with the public interest in disclosing teratogenic risk data. • The criteria used to decide when safety data, trial results, or risk-related evidence is withheld or published. 2. Transparency Obligations Imposed on Pharmaceutical Companies Related to Teratogenicity Please clarify what specific transparency requirements pharmaceutical companies must fulfil when interacting with the MHRA, particularly with respect to teratogenicity evidence, including but not limited to: 2.1 Pre-Clinical and Clinical Study Transparency • Requirements for companies to disclose pre-clinical developmental and reproductive toxicity (DART) studies that assess teratogenic risk. • Obligations to publicly register and report clinical trial results that include teratogenicity endpoints, including timelines and public registries used. 2.2 Labelling, Risk Communication, and Pregnancy Guidance • Mandatory requirements for companies to include teratogenic risk information in product labelling, patient safety leaflets, pregnancy warnings, or healthcare professional materials. • Whether plain-language pregnancy exposure guidance and teratogenic risk summaries must be provided to the MHRA and made publicly available. 2.3 Post-Marketing Surveillance and Safety Reporting • Obligations of Marketing Authorisation Holders (MAHs) to report reports of congenital anomalies or suspected teratogenic outcomes in pharmacovigilance systems (e.g., Yellow Card reporting). • Timelines, formats, and public disclosure expectations for such post-marketing safety reports. 2.4 Anonymised Data Sharing and Accessibility • Whether companies are required to share anonymised individual-level teratogenicity data or study datasets with the MHRA and, if so, whether there is an expectation for such data to be made available to the public or research community. 2.5 Conflict of Interest and Industry Conduct Transparency • Expectations or requirements relating to transparency of industry involvement in research, advisory committee participation, or funding associated with teratogenicity studies. 3. Public Access to Teratogenicity Information 3.1 Public Platforms and Accessibility • Please specify which platform(s) the MHRA uses to make teratogenicity-related regulatory information available (e.g., public registers, databases, safety update pages) and how individuals can access this information at no cost. 3.2 Format and Clarity • Whether the MHRA has commitments to publish information about teratogenic risk in readily understandable formats for patients, researchers, clinicians, and the public (e.g., plain language summaries, structured risk tables). 4. Request for Documents and Policies I respectfully request copies (or links) to the following MHRA documents, policies, and guidance: 1. MHRA’s current policy on transparency of teratogenic risk assessments and communications. 2. Regulatory guidance on teratogenicity data expectations from pharmaceutical companies (pre-clinical, clinical, post-marketing). 3. Policy or guidance documents regarding public disclosure of teratogenicity data and safety signals. 4. Any internal standards or frameworks used by MHRA to evaluate and disclose teratogenic risk information
Response
See attached
Documents
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