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Risk Management Plan (RMP)

Risk Management Plan (RMP) is an obligatory document for each newly registered medicinal product. Its aim is, on the one hand, to characterize the safety profile of a given drug, and, on the other hand, to broaden the knowledge of potential risks for the patient and to plan measures to minimize these risks.

What to look for in the preparation of the RMP?

Risk Management Plan should be prepared on a special template published by the European Medicinal Agency (EMA). Failure to adhere to the applicable template increases the risk of comments from Competent Authorities (CAs), thus reducing the chances of a positive evaluation and obtaining a Marketing Authorization (MA).

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An important element of each RMP is also a list of safety concerns, divided into identified, potential and missing information risks. An RMP with an appropriately adapted list of risks is a positive aspect of a medicinal product.

It is also important to carry out activities in accordance with the Harmonization of Risk Management Plan Project (HaRP), introduced in 2019, which aims to harmonize the list of risks included in the RMP. Thus, to avoid comments from CAs, the principles of the HaRP methodology should be applied to each new RMP. You can find out more about it here (slide 8-11, please note that this material is in Polish language).

How to meet changing requirements?

In a world of constantly changing requirements regarding Pharmacovigilance (PhV) and RMP, each Marketing Authorization Holders (MAHs) should ensure that documentation of medicinal products is prepared in accordance with the applicable requirements and was regularly updated. Preparation of an RMP that meets the requirements and suggestions of competent authorities, e.g. with regard to the current RMP template, or the application of HaRP principles, is beneficial for MAHs not only during the registration procedure, but also later, in terms of daily pharmacovigilance monitoring activities.

Collaboration with experts

Keeping track of the latest Competent Bodies requirements is much easier with the support of an experienced and well-informed team. At SciencePharma, we offer both the preparation of a completely new RMP, or the service of updating an existing document - depending on the individual needs of the Marketing Authorization Holders. When developing an RMP, we use the current definition of "risk" and the newest RMP template. We ensure timely preparation of high-quality documentation, which translates into a smooth assessment and obtaining CAs approval - without unnecessary downtime and delays during the procedure.

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Our experience

  • We have carried out full registration or harmonization procedures on behalf of MAHs for over 150 medicinal products.
  • Our experts analyze the safety profile of each medicinal product individually, thanks to which we have successfully prepared over 50 RMPs for various medicinal products.
  • So far, we have received only positive feedback from CAs in relation to the RMPs we are preparing.
  • We constantly expand our knowledge of the current requirements and registration procedures by participating in internal and external trainings.

More information about the services we provide and our experience can be found here.

If you are interested in cooperation, please contact us. Our experts will be happy to answer all your questions.
 

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