Risk management in pharmacovigilance is vital for the safe use of medicines and safeguarding the health of patients. For industry professionals, risk management is a way to ensure that the benefits of the medicinal product outweigh the risks by a wide margin both at the individual and the target population level.
Already a challenging task, the COVID-19 pandemic has only increased the complexity of pharmacovigilance risk management due to the rapid development of multiple COVID-19 vaccines and treatments.
On the 3rd of March, we have conducted a webinar titled “Current Challenges in Pharmacovigilance Risk Management”.
During this webinar, we discussed with the participants the main challenges in pharmacovigilance risk management, including those related to additional risk minimisation measures needed for medicines and vaccines approved following accelerated procedures. We also proposed possible ways to overcome these challenges and opened the floor for participant questions.
During this Q&A session of the webinar, we have received so many questions, that we decided to turn them into a blog. We hope you enjoy the read!
Are EU RMP accepted by FDA and other extra EU countries?
The EMA requires the presentation of the Risk Management Plans for every initial market authorisation application. US FDA requires a formal risk minimisation program that is called Risk Evaluation and Mitigation Strategies, but it should be implemented only for certain products, not for all. At the same time, for example, Canadian and also Korean health authorities accept the submission of Risk Management Plans in EU format even if they do not require standard submission of RMP for all products. The regulations differ from country to country, that is why we recommend double-checking them before submitting your RMP.
What is meant by missing information in the context of pharmacovigilance risk management?
According to the EU guidance on RMP, exclusion criteria from the clinical trial development program should be included as missing information but only when they are relevant for the approved and proposed indication and might be associated with additional risks of clinical significance.
How frequently generic RMP needs to be submitted to MHRA or EMEA? Is there a guideline with clear instruction for submission timeliness by generic MAH?
There are no pre-determined timelines for RMP updates. Module V states “An RMP update is expected to be submitted at any time when there is a change in the list of the safety concerns, or when there is a new or a significant change in the existing additional pharmacovigilance or additional risk minimisation activities”.
In the case of the generic product, the EURD list foresees the presentation of a PSUR under a PSUSA procedure, so in the assessment report the assessor may require the MAH to update the list of safety concerns by applying for an RMP update.
The pregnancy follow-up form that we are used to has additional info in case of ADR experienced by a pregnant woman. Is it to be included in RMP, even if it is a routine pharmacovigilance activity?
No, the questionnaires to be included in the RMP are those aimed to collect FU info on suspected adverse reactions of special interest.
Guidance for health care providers and for patients – is it an additional risk minimisation measure or routine?
It is considered an additional risk minimisation measure.
Is it correct to say that a contraindication should never be considered as missing information?
Contraindication is a condition or repopulation that should not be treated with the product, so there is no real need to collect more information on this topic and that is why conditions/ populations included in the contraindications of EPS should not be considered missing information.
Is there any obligation for additional risk minimisation measures for generic MAH?
Only if the reference product has them.
Is there a GVP module related to PAES?
There is no GVP module related to PAES, however, you can use this guidance by EMA as a reference.
Where is the major impact on RMP due to Brexit?
I believe that it will regard the RMP updates which could be not anymore aligned to the EU countries such as for timing and contents.
Is PAES always obligatory for products authorised through accelerated procedures?
PAES is not obligatory for vaccine marketing authorisation applicants. It is also rare that the EMA impose PAES. When it comes to vaccines, it’s the PASS studies, that are part of additional pharmacovigilance activities in the Pharmacovigilance Plan, that should collect also effectiveness data.
Which exclusion criteria in clinical studies should be considered as missing information in the RMP.
The definition and the identification of safety concerns is a challenging task. When it comes to missing information, not all exclusion criteria in a clinical study can be considered missing information to be put in the RMP because the definition says that the missing information included in the risk management plan is only relevant to the approved and proposed indication.