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Regulatory Working Group

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 are made to help authorities increase efficiency and maximize the use of resources, 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 by country regulatory agencies takes time and is not always successful.

Vaccine manufactures view the challenges from the customers’ perspective, which may be different from WHO’s perspective. While WHO retrieves information of the regulatory requirements and procedures mostly through the assessments that they perform, manufacturers have “real life experience” through the requirements imposed, the questions received, and the timeframe taken by NRAs to process submissions. On this basis, the regulatory experts working group members believe that there is scope to contribute to the efforts made by WHO and others to strengthen regulatory capacity by increasing stakeholders’ awareness of the challenges, and by making proposals that could lead to improvements.

The work needed is not limited to fostering 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.

In the context of the COVID-19 pandemic, there are opportunities for the group to foster implementation of alignment and reliance mechanisms that may become acceptable for COVID vaccines both for Emergency Use Approvals and further registration in countries, which if successfully implemented, could be perpetuated in the future for other vaccines.

This RWG sees a role for itself also in supporting the development of facilitated regulatory mechanisms required for the management of post-approval changes in the context of COVID vaccines, this being an important challenge. Any new mechanisms that may be established may pave the way for future use for routine vaccines.

Objective

The objective 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 can influence regulators in implementing some of the proposed changes for improvement. 

Focus

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 and opportunities for improvement of post-approval changes (PACs) management all along the vaccine lifecycle. It has developed a position paper, and three papers that have been published in Vaccine, a peer reviewed Journal. 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 ten DCVMN member companies. The group is led by a Chair and a Co-chair. (REVISED)

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 has been a decision taken by the working group members 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 them 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 take place quarterly, largely 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. Additional webinars can be convened at any time, to discuss specific issues of interest or concern of manufacturers.

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 company colleagues and managers to enhance the analyses undertaken and the impact of decisions and actions taken. Participants whose situation changes and can no longer serve on the group will inform DCVMN to allow another participant to be identified.

30th April 2021

List of participants (as of 27th January 2022)

Name SurnameCompanyCountry
S. Comellas- CochairSinergium BiotechArgentina
S. GairlolaSerum Institute of India, LtdIndia
Y. XuCNBGChina
I. NurnaeniPT BiofarmaIndonesia
Ch. RoyBharat Biotech International LtdIndia
J. JellinBiovacSouth Africa
A. WongWalvaxChina
J. ChenBravovaxChina
P. Nagarkar – ChairSerum Institute of India, LtdIndia
N. De Clercq*GSKBelgium
L. Le Palaire*Sanofi PasteurFrance
L. Scheppler*Jansen Vaccines, Branch of Cilag GmbH InternationalSwitzerland
M. McGoldrick*Merck Sharp & DohmeUSA
J. Dias*PfizerBelgium
P. Barbosa*IFPMA
A. Basso*Sanofi PasteurFrance
B. HendrickxIndependent ConsultantSwitzerland

*Representatives from IFPMA member companies

IFPMA representatives are regularly y invited to the Working Group discussions, and a close scientific collaboration has been established b between the two groups and the representatives are also co-authors in the WG publications, according to contributions, as appropriate.

  • March 24, 2022
  • January 11, 2022
  • October 15, 2021
  • June 18, 2021
  • March 22nd, 2021
  • December 17, 2020
  • October 13, 2020
  • July 30, 2020
  • June 4, 2020
  • March 25, 2019
  • September 3-7, 2018
  • January 11-12, 2018
  • May 15-16, 2017
  • March 6-10, 2017

Documents
2022
Reg WG meeting minutes March 24, 2022
Reg WG meeting minutes Jan 11, 2022
2021
Reg WG meeting minutes October 15, 2021
Reg WG meeting minutes June 18, 2021
Reg WG meeting minutes March 22nd, 2021
2020
Reg WG meeting minutes December 17, 2020
REG WG meeting minutes October 13, 2020
Reg WG meeting minutes July 30th, 2020
Reg WG meeting minutes June 4, 2020
2019
Reg WG workshop minutes March 26, 2019
2017
Reg WG workshop minutes March 6-10, 2017
Reg WG Workshop report May 16, 2017
Strategy to move the alignment proposal forward

Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers
https://www.sciencedirect.com/science/article/pii/S259013622030022X

Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures: An industry perspective. Delepiane N, et al.
https://www.ncbi.nlm.nih.gov/pubmed/31027928

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes. Delepiane N, et al.
https://www.ncbi.nlm.nih.gov/pubmed/29724510

Handling of Post-Approval Changes to Marketing Authorizations: IFPMA report, 2019
https://www.ifpma.org/wp-content/uploads/2018/11/IFPMA-PACs-Brochure.pdf

EMA procedural advice for medicinal products intended exclusively for markets outside the European Union under Article 58 of Regulation (EC) No 726/2004 in the context of co-operation with the World Health Organisation (WHO)
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-medicinal-products-intended-exclusively-markets-outside/2004-context-cooperation-world-health_en.pdf

Emergency Use listing procedure
https://www.who.int/immunization_standards/vaccine_quality/EUL/en/

POLICY- Evaluating and publicly designating regulatory authorities as WHO listed authorities: 2019 Draft for comments https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_828_Policy_on_WHO_Listed_Authorities.pdf?ua=1

Collaborative procedure between the World Health Organization (WHO) Prequalification Team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines. WHO TRS 996, Annex 8 : 2016 (here attached as file named WHO TRS 996 Annex 08)
WHO TRS 996 Annex 08 (PDF)

WHO Listed Authorities (WLA) consultative meeting
WLA consultative meeting SH (PDF)
Comments WLA WHO 2nd july SD (PDF)

Documents
Suggested template for alignment of module 1-3
Application form abstract
Model Application form
Procedures

CRP implementation

Steps for CRP implementation