Some pharmaceutical companies have begun reaping the benefits of the revised EU template for preparing their risk management plans (RMPs) by voluntarily using it in their submissions.
The use of the revised template – whose purpose is to facilitate a more fit-for-purpose RMP, focused on minimizing, mitigating and managing the important known risks and missing information of a medicinal product – will become mandatory for some RMP submissions after Sept. 30 this year, and for all types of submissions as of March 31, 2018.
The revised RMP template has been available for use by companies on a voluntary basis since March 31, 2017.
A spokesperson for European Medicines Agency told Pink Sheet that companies have begun using the template voluntarily, and the agency’s human medicines evaluation committee, the CHMP, has already issued a positive opinion on the marketing authorization application of a product (Spherox- spheroids from human autologous matrix-associated chondrocytes) that used the revised version of the RMP template.
There are also a few post-marketing RMP updates currently under assessment where the marketing authorization holder has used the revised version of the RMP template, the spokesperson added.
For companies that still prefer to use the earlier version of the template, transitional arrangements have been put in place to give them more time. For example, the EU Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has clarified in an updated pharmacovigilance guideline that companies can use the old RMP template:
- throughout the initial decentralized procedure for marketing authorization applications (MAAs) submitted until Sept. 30, 2017; and
- for all other applications submitted via the mutual recognition procedure (including applications for a new marketing authorization via the mutual recognition or the repeat use procedure) until March 30, 2018.
For centrally authorized products, the EMA has clarified that companies can use the old RMP template:
- until Sept. 30, 2017 for RMPs submitted with the initial MAA and for responses to Day 120 list of questions; and
- until March 30, 2018 for all other RMP submissions, including Day 91 responses for an initial application under accelerated assessment.
In case of nationally authorized medicines, some national competent authorities are also issuing their own guidance on this front. For example, the Swedish Medical Products Agency announced in August that companies can use the old RMP template throughout initial MAAs submitted until Sept. 30, 2017.
The RMP template was revised along with the EU RMP guideline (good pharmacovigilance practice – Module V) earlier this year following an extensive public consultation. The revision of the template and the RMP guideline represented the first major significant change undertaken by the EMA to simplify the submission and maintenance of RMPs by drug companies. (Also see "EMA Revises Guidance On Risk Management Plans To Address Industry ‘Misunderstandings’" - Pink Sheet, 10 Nov, 2016.) (Also see "EMA Proposes Significant Changes To Guidance On Risk Management Plans And Template" - Pink Sheet, 11 Mar, 2016.)
The EMA said that the industry had received the RMP template and guideline “positively” and had provided feedback throughout the public consultation period as well as following the publication of the updated template.