Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the effectiveness of the medicines licensing process for novel medications in being able to detect potential teratogenicity prior to the medicine being made available to patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which uses internationally standardised guidelines and principles in its assessment and approval of medicinal products.

Teratogenicity is a complex issue which requires an overlapping approach, encompassing preclinical risk evaluation and assessment, close monitoring during clinical trials, and post-authorisation surveillance measures.

The preclinical assessment of teratogenicity is conducted in accordance with ICH S5(R3) Guidelines on the detection of reproductive and developmental toxicity for human pharmaceuticals. The guideline recommends the evaluation of potential teratogenicity in two animal species, typically rodent and non-rodent. The drugs are administered to pregnant females, and teratogenic effects are examined in the offspring. While there is some flexibility, these studies are mandatory. Whole embryo culture systems and other in vitro methods may be used for rapid screening.

Regarding potential reproductive toxicity, which covers teratogenicity, for participants in clinical trials, it is required that a preclinical evaluation of the male and female reproductive organs is conducted, assessed, and confirmed as acceptably safe prior to the inclusion of fertile human participants into early phase clinical trials. Furthermore, appropriate precautions and safety monitoring during the exposure of such participants minimises the risk of unintentional exposure to an embryo or foetus.

Any detected signals or predicted risks of teratogenicity are outlined in the labelling requirements, which may emphasize contraception mandates during the clinical trials and following marketing authorisation approval.

A system of safety reporting and reviews by sponsors and the MHRA is in place to ensure that any safety information relating to concerns that emerge from a clinical trial or following marketing authorisation is addressed in the interests of patient safety.