RMPs cover a medicine's safety profile and include measures taken to prevent or minimise any harm to patients from the medicine. All medicines have both benefits and risks; a medicine is authorised only if the benefits outweigh the risks. The RMP details the known concerns about the safety of the medicine and how they can be managed. When a medicine is first authorised, it is impossible to know everything about its safety as the medicine will have been tested in relatively few patients and for a limited duration. Some side effects are very rare, or occur only in patients with other conditions or particular genetic makeup. All medicines are carefully monitored after marketing (pharmacovigilance), so that new side effects can be detected quickly, and regulatory authorities can ensure that the benefits outweigh the risks at all times. The RMP may also outline any additional studies that have been recommended at the time of licensing to provide more information on the medicine’s safety profile.
RMPs include information on:
- a medicine's safety profile;
- how its risks will be prevented or minimised in patients;
- plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine;
- measuring the effectiveness of risk-minimisation measures.
Situations When A Risk Management Plan Should Be Submitted In Egypt
- A RMP or an update, as applicable, may need to be submitted at any time during a product‘s life-cycle, i.e. during both the pre- and post-authorisation phases.
- For all new marketing applications: the risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned shall be submitted, together with a summary thereof.
- Situations, in addition, where a RMP or RMP update will normally be expected include:
- with an application involving a significant change to an existing marketing authorisation:
- new dosage form;
- new route of administration;
- new manufacturing process of a biotechnologically-derived product;
- paediatric indication;
- other significant change in indication;
- A significant change in indication is a change of authorised indication(s) of a medicinal product where the new treatment target population differs materially from the one for which the medicinal product was previously authorised. This includes (but is not limited to): a new disease area, a new age group (e.g. paediatric indication) or a move from severe disease to a less severely affected population. It may also include a move from 2nd line or other therapy or for an oncology product a change to the concomitant medication specified in the indication.
- at the request of the national medicines authority when there is a concern about a risk affecting the risk-benefit balance;
- with a submission of final study results impacting the RMP;
- With a PSUR for medicinal product, when the changes to the RMP are a direct result of data presented in the PSUR.
- at the time of the renewal of the marketing authorisation if the product has an existing risk management plan.
- The need for a RMP or an update to the RMP should be discussed with the national medicines authority, as appropriate, well in advance of the submission of an application involving a significant change to an existing marketing authorisation.
- An updated RMP should always be submitted if there is a significant change to the benefit-risk balance of one or more medicinal products included in the RMP.