EMA is waiting for the first male contraceptive projects in order to prepare authorization rules.

The European Medicines Agency says it is ready to advise researchers and companies developing male contraceptives, but it has not yet received any concrete projects. Without data on the products under development, the EMA cannot establish detailed guidelines for their evaluation and authorization.

The European Medicines Agency is waiting for researchers and companies working on male contraceptives to present the first concrete projects, so that the agency can prepare guidelines for the development and evaluation of these products. The EMA says its door has been open since November, but no developer has requested advice until now.

In short

The EMA says it is ready to work with developers of male contraceptives, but it has not yet received a concrete project. The agency needs information about the products, studies, and real difficulties encountered by researchers in order to formulate useful recommendations.

Companies and scientists are asking for clear European guidelines regarding the evidence required for the evaluation of a male contraceptive. The EMA responds that it cannot develop detailed instructions in the absence of products that are sufficiently advanced in development.

The agency can provide scientific advice before a marketing authorization application is submitted. Early discussions can clarify how studies should be designed, what safety data is needed, and how the product's efficacy should be demonstrated.

A European-level authorization would allow access to a common market, instead of separate procedures in each state. In a hearing, MEP Peter Liese said that developers consider this perspective important for the commercial viability of the products.

The EMA participated in a meeting in November with experts and developers and informed them that it can start the dialogue. The agency's director, Emer Cooke, said, however, that since then, no one has presented a project on which more precise guidelines can be built.

The subject was discussed in the European Parliament's Public Health Committee during a hearing with the executive director of the European Medicines Agency, Emer Cooke. MEP Peter Liese said that the burden of contraception mainly falls on women and that there are researchers and companies trying to develop alternatives for men.

According to Liese, developers are not seeking separate national procedures, as a European authorization would give them access to a much larger market. They argue, however, that they need guidance from the EMA to know what type of studies and what evidence will be necessary before a product can be authorized.

The EMA can provide scientific advice even in the early stages of development. The agency can discuss with researchers about designing clinical studies, the populations that need to be included, the criteria used to measure efficacy, and how adverse reactions should be monitored.

Cooke described the situation as a problem where each party is waiting for the other. Developers are asking for guidance first, while the agency needs concrete projects and data to understand what recommendations are necessary and what difficulties arise in practice.

The EMA participated in a meeting in November dedicated to male contraception and then communicated that it is ready to discuss with developers. "Our door is open," Cooke said in Parliament, adding that until now, "no one has knocked on it."

The agency has not announced the immediate development of a guideline or a timeline for the emergence of male contraceptives. The next step depends on researchers and companies, who need to present the products under development and request advice.

The EMA's guidelines would not replace the individual evaluation of each drug. However, they could explain to developers what evidence they need to produce to demonstrate that a contraceptive is effective, that its risks are acceptable, and that its benefits outweigh any potential side effects.

The transcript of the hearing does not identify the projects under development, the companies involved, or the stage of research. It also does not specify whether any product is close to starting the necessary clinical studies for a future authorization application.

https://2eu.brussels/ro/news/ema-asteapta-primele-proiecte-de-contraceptive-masculine-pentru-a-putea-pregati-reguli-de-autorizare