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The currently valid Regulation (EU) 536/2014 on clinical trials with medicinal products for human use brings some innovations that are of great importance for patients who participate in clinical trials and patients with a need for innovative therapies. These concern patient protection, especially for vulnerable patient groups, as well as the conditions for further use of data obtained in clinical trials. The introduction of the largely publicly available information system CTIS (Clinical Trials Information System) will significantly improve the transparency of ongoing clinical trials. However, the possibilities of redacting commercially confidential information and postponing the publication of trial-related data and documents for several years may affect the scope of transparency. The request for the sponsor to provide a summary of the protocol and a summary of results of the clinical trial in layman's language (within one year after the end of the trial) also means a massive improvement in transparency for patients, even if this period seems too long, especially for patients with life-threatening diseases. Not all patient-relevant goals originally hoped for have been achieved. The systematic involvement of patients and patient organisations in the clinical trial protocol design is not required by the legislation enacted in 2014. The involvement of patients in the ethical review of the authorisation application dossier is only recommended in the introductory justification, but not codified in the law., (© 2022. Springer-Verlag GmbH Deutschland, ein Teil von Springer Nature.)

Less than 10% of medicines approved by the FDA since 1980 have provided enough information as regard risks for birth defects associated with their use [1]. Nevertheless, it is estimated that over 90% of pregnant women take over-the-counter (OTC) or prescription medication [2]. Considering the fact that the use of medication in the period before conception and during lactation can also influence the development of the child, information on the impact of their usage during reproductive life is important for everyone. The lack of clear information on this topic results in situations where life-saving medication is discontinued, withheld or used in a reduced dosage by pregnant women, while on the other hand medicines with (potential) toxic effects are taken. This is unacceptable and it is a major public concern that must be addressed. Currently, Europe lacks a robust and comprehensive information system about medication use in reproductive life (preconception, pregnancy and lactation). In order to improve maternal health, and subsequently the health of our next generation, reliable and up to date information should be made available. It should be readily accessible for both health care providers and women who are considering getting pregnant or who are already pregnant. In order to tackle this gap in public health, this paper describes current knowledge of the use of medicines before and during pregnancy. It calls upon all stakeholders involved in medical care, research and medicine regulation, such as policy makers, regulators and governmental agencies, to take action to protect patients and improve public health., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)