Regulatory Optimisation Group (ROG)

The Regulatory Optimisation Group (ROG) is a an HMA subgroup focused on regulatory/business optimisation, under HMA Multi Annual Working Plan priority Optimisation of the regulatory operations, objective 2, Strive for operational excellence. The background, mandate, composition and working approach of the ROG are described in the “Mandate HMA subgroup on Optimisation of the network: Regulatory Optimisation Group” (as agreed by HMA dated February 20th, 2017).

The European regulatory network has over the past number of years made significant changes in the regulatory operations for the regulation of both human and veterinary medicines, through collaboration between telematics, regulatory and scientific groups and industry representatives. These changes have for the most part been based on regulatory procedure changes, utilising, where applicable, information technology to enable the delivery of the legal and business requirements.

The ROG is a cross-functional group, consisting of regulatory-, business- and IT-experts from NCA, EMA, CMDh and CMDv, and industry, both from human and veterinary domains. The ROG will identify and evaluate concepts to improve the operation of the network and present problem statements and business cases for the delivery of these initiatives to HMA for review and approval. It provides a forum for evaluating and communicating these concepts and approaches with input from the different stakeholders.

The ROG is composed by business, regulatory and IT experts from both veterinary and human domains within NCAs and EMA and from CMDh and CMDv, as outlined in the table below. Representatives of the innovative, generic and non-prescription industry are involved  in the ROG  as participants (without voting rights) in order to fulfil the MAWP’s ambition to liaise in meeting the goals of the key business priority Optimisation of the regulatory operations. The group may be supported in specific actions by other co-opted stakeholders, as required. The mandate for sending business cases for approval to HMA is with the regulatory representatives from NCAs and EMA.

 

Chair

NCA (appointed by the HMA lead and support of MAWP key business priority Optimisation of the regulatory operations)

Co-Chair

EMA

CMDh

2 representatives

CMDv

2 representatives

Business Representatives

3 NCAs representatives (human and vet, small and large agency), 2 EMA

Information Technology

3 representative (2 NCA, 1 EMA) from which 2 ITDEC

Business Analyst 

2 representatives (NCA or EMA)

Industry stakeholders     

6 representatives  (human and vet, different organisations, expertise on regulatory, business and IT)

The chair of the ROG is Stan van Belkum, deputy director of the Medicines Evaluation Board (MEB) in the Netherlands.

The Co-chair is Zaide Frias from the EMA.

E-mail ROG secretariat (MEB): ROG@cbg-meb.nl

Stan van Belkum (MEB); ca.v.belkum@cbg-meb.nl

Zaide Frias (EMA); Zaide.Frias@ema.europa.eu

During preparatory work, an annual work plan for 2017 for the ROG has been drafted, focussing on regulatory optimisation of IA variations. Within the focused topic of IA variations, the breadth of work can be wide as many aspects of the regulatory processes - both human and veterinary - within NCAs and industry will be addressed in this business case. Examples of possible interlinked topics which could become part of the discussions on IA variations include; fee-systems, single assessment of manufacturing of substances, eSmPC/PIL, etc.

One of the strategies of the ROG will be to incorporate a modern style of work ethos; fostering effective teamwork by combining teambuilding with an in-depth, out-of-the-box and open dialogue between the regulators and industry partners in ROG, to fully elaborate the issues, problems and proposed solutions.

Work will be conducted by means of virtual meetings, information gathering, workshops and face-to-face meetings. For efficient progress in specific topic areas, smaller working groups constituted of different members of the stakeholder groups and/or dedicated topic experts may be created.
Secretarial support to the ROG will be provided by the chair of the group. EMA will provide secretarial support when consultation with its scientific committees is required.

The group uses a workspace for document drafting and communication and the site is maintained by the support group of the ROG; the ROG should limit emails and document distribution.

The ROG work plan and relevant presentations will be published on the HMA website to ensure transparency.  The chair or co chair will be available for report at each HMA plenary session following approval from HMA MG.

Each authority will bear their own costs and time investment related to their representative’s participation in the ROG.

Optimising the operation of the network is one of the 11 key business priorities of the HMA Multi-Annual Work Plan (MAWP) and, under this theme, objective 2 Strive for operational excellence has five goals which are:

  • Goal 2.1 - Optimising the regulatory operations
  • Goal 2.2 - Reduce the regulatory burden
  • Goal 2.3 – A network which is operationally efficient and cost effective, minimising as much as possible the administrative burden for the pharmaceutical industry and other stakeholders
  • Goal 2.4 – A network which is sustainable and able to cope with future challenges
  • Goal 2.5 – Strive for operational excellence

The efficiency and effectiveness of the regulatory environment is a key factor in a global setting and the contribution to potential legislative changes at an EU level, however the optimisation of the current regulatory framework, within the current legislative provision, will contribute to successfully implementing this strategy.

The proposal for new veterinary legislation requires the Network to review regulatory operations optimising the various Telematics initiative in development or operation within the network. This also provides an opportunity to utilise these changes to maximise efficiency across various domains, where applicable.

Delivering on the actions within this theme from the MAWP requires a combination of skills like business process engineering, regulatory, scientific and information technology knowledge, much of which is already available within the network, but split across many groups that do not always have harmonised objectives.

The First Official ROG Meeting

The Regulatory Optimisation Group (ROG) is an HMA sub group focused on regulatory/business optimisation, under HMA Multi Annual Working Plan priority optimisation of the regulatory operations, objective 2, “Strive for operational excellence”.

On the 14th of June, the ROG met in London to hold its first official meeting with full regulatory and industry representation covering both human and veterinary products. The agenda for the meeting included the updating the group on its current status: provision of  feedback from the meeting of the previous day with the EU ISO IDMP / SPOR group on baseline data gathering for the first business case on type IA variations; collection of other ideas for simplification or optimisation of regulatory process in EU Network; and to make a start on identifying relevant IT considerations and potential solutions (largely from the EU Telematics Roadmap). Communication on the ROG initiative and its progress is planned to be achieved by means of press releases and updates on HMA/EMA websites but also likely timely information through other professional membership forums.

The group agreed on the details of the variation type IA baseline data collection exercise, and final data collection is planned for mid September 2017. The first business case is scheduled to be presented at the November HMA-meeting. The creation of business cases from the data collections should be supported with LEAN methodology-experience. Several other topics for possible business cases have been identified, and sub groups will be set up as appropriate to elaborate those topics.

The alignment with the EU ISO IDMP/ SPOR programme is an opportunity to reduce administrative burden and the operational wastefulness currently applied towards the provision of “do and tell” information in the form of Type IA variations. However even the automation of initial type IA variations based on OMS address data requires a functioning P-database with manufacturing information present.

The ROG has been updated with revised timelines and details of phasing for the first iteration of the SPOR initiative on the medicinal products (PMS) data base, upon which optimal delivery of the Type IA process improvement is strongly dependent. The ROG will therefore investigate alternative business process solutions, including those not necessarily dependent on IT. This line of thought opens the way to identify opportunities for simplification of regulatory requirements and processes.

Despite the likely challenge presented by SPOR planning, this first meeting of the ROG is considered a great success: work has started; and the enthusiastic involvement and commitment from all participants is confirmed.

Stan van Belkum (chair) & Zaide Frias (co-chair)