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Terms of reference

Background:
Challenges faced by manufacturers in their attempts to register vaccines in countries across the world is well known and recognized by all immunization stakeholders. An important part of WHO Essential Medicines Department activities, through their regulatory unit, is to help authorities worldwide to improve their regulatory capacity to increase their efficiency for the regulation of medicines including vaccines. Efforts to help authorities include recommendations and training on how to best use resources to maximize efficiency while maintaining the quality of the work.

Alignment of requirements, streamlined procedures and reliance on work done by mature regulatory authorities and by WHO prequalification are strongly advocated as reliable mechanisms leading to increased efficiency in regulatory oversight. However, integration of these concepts and adoption of such recommendations takes time and is not always successful.

WHO and other stakeholders working directly with regulatory authorities view the challenges from the perspective of these authorities. Vaccine manufactures though, believe that there is scope to contribute to these efforts by increasing stakeholders’ awareness of the challenges by reporting their perspective, and by making proposals that could lead to improvements.

The work needed is not limited to the foster improvement of implementation of regulatory procedures and requirements in the target countries but also and most importantly by participating and providing inputs for the development and/or update of international requirements for production, control, GMP, GCP, GDP and other so that these remain within a reasonable level of stringency and applicable in practice. Working closely with regulatory networks and other decision makers in this field remains an important aspect where manufacturers’ involvement is crucial.

Objective:
The purpose of the regulatory experts working group is to share best practices in regulatory science and regulatory affairs. The group seeks to collaborate for the identification of regulatory challenges at both the pre-marketing and post-marketing stages in the vaccine life cycle, and to explore potential opportunities for increased efficiency of regulatory processes worldwide. The proposals from the group are shared widely with partners and vaccine stakeholders who are in a position to influence regulators in implementing some of the proposed changes for improvement.

The focus of the group has been at the beginning to identify challenges and opportunities for improvement of the vaccine registration procedures and processes (pre-registration stage) in countries; and recently to identify challenges an opportunities for improvement of post-approval changes (PACs) management all along the vaccine lifecycle. It has developed a position paper, and two papers that have been published in Vaccine, a peer reviewed Journal. The third paper on PACs management, currently under development, will be submitted for publication shortly. The focus of the group is also to identify needs for strengthening regulatory capacity in member companies and to support their development.

Authority:
Group participants from DCVMN members act on a voluntary basis and need to declare any conflicts of interest they may have regarding any work undertaken. The DCVMN Executive Board will have the authority of determining the usefulness of any work undertaken and approving its dissemination.

Composition:
The group is composed of Regulatory Affairs and/QA staff from seven DCVMN member companies. Ideally the group should be expanded to around10 companies. A Chair and a Co-chair have to be elected.

In addition, the unusual characteristic of this group is that it collaborates very closely with IFPMA, and representatives from five IFPMA member companies participate routinely, although informally, in the group. Inclusion of IFPMA member companies in the meetings and activities such as publications, has been a decision taken by the working group members in order to join forces and to elaborate proposals that are the result of a consensus among a broad group of vaccine manufacturers. It was anticipated that collaboration and joint proposals would result in increased attention by WHO and other important stakeholders; and such has been the case so far.

Criteria for participation in the expert group:
Companies represented in the group are mostly companies with prequalified vaccines that supply these vaccines internationally. Expertise of participating companies and their representatives in worldwide distribution of vaccines is important because these are the companies that understand the regulatory challenges that are faced.

Operations:
A specific annual work plan will be agreed upon, including the specific topics to be covered with timelines and deliverables. Group meetings will largely take place through remote communication (telephone calls, WebEx, and email), but also face-to-face meetings during which the Chair or co-Chair and at least half the participants are attending. Any group meeting (telephone, email or face-to-face) will have a specific set of points for discussion and a required minimum quorum (Chair or co-Chair plus half the participants), ensuring decisions are taken in a collegial manner. Discussions will aim for consensus but also note any specific regional or company set-up differences that may exist and these should be respected.

Duties and responsibilities:
Each participant will act in the capacity of the corporate member and best contribute to the specific annual agenda. This will include reviewing specific topics being addressed and, if relevant, adding specific analysis of the country situation in which the company is located. Participants will be expected to discuss topics with their colleagues to enhance the analyses undertaken. Participants whose situation changes and can no longer serve on the group will inform DCVMN to allow another participant to be identified.

(17th April 2020)

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