The COVID-19 pandemic is causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies.
Due to this global public health emergency, the European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. The Q&A document explains some regulatory flexibilities that can be applied to help marketing authorisation holders cope with the consequences of the pandemic, while ensuring a high level of quality, safety and efficacy for medicinal products made available to patients in the EU.
The introduced measures (some of them reserved for crucial medicines for use in COVID-19 patients) cover different areas of the regulation of medicines such as:
- marketing authorisations and regulatory procedures;
- manufacturing and importation of active pharmaceutical ingredients (APIs) and finished products;
- quality variations;
- labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU.
Marketing authorisation holders are encouraged to consult the EMA website section regarding Coronavirus disease (COVID-19) regularly as it will be continuously updated.
Asphalion is offering all its expertise in Regulatory Affairs during this exceptional situation. We would like to support in whatever is needed at this time, either in preparing technical documents or helping in the request of clinical investigation authorisations, so do not hesitate to contact us if we can help: firstname.lastname@example.org