Work packages 1-3: Coordination, dissemination and evaluation

Taking over from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK as of April 2019, the National Agency for the Safety of Medicines and Health Products (ANSM) in France was responsible for the first three work packages:

• Coordination of the project: ANSM had to verify that the Joint Action is completed on time, within budget, and with high–quality deliverables
• Dissemination of the information: ANSM had to collect and circulate the deliverables to the target groups
• Evaluation: ANSM had to check that the implementation of the project was developed as planned.

Work package 4: Joint Manufacturer Inspections

As part of their work package to improve manufacturer inspections, ANSM (France) and the National Authority of Medicines and Health Products (INFARMED) in Portugal, in collaboration with European partners, were responsibles for:

• Developing methods, agreed tools and guidance for a joint, consistent and proactive approach to manufacturer inspections by competent authorities: At the beginning of the project, various approaches and differences between Competent Authorities as how they approach market surveillance were identified. A guidance document intended to define and specify good practice by sharing and exchanging information on performing inspections was developed.
• Establishing specific inspection scopes and objectives to complement those conducted by conformity assessment bodies:The joint manufacturer inspections are complementary to the existing system in order to reinforce the current performances and permit the harmonisation of joint manufacturer inspections and not current national manufacturer inspections. Work package 4 developed a harmonised guidance regarding joint inspection planning strategies.
• Identification of sources of information to be used to focus on during the Joint inspections to achieve maximum public health impact: An inspector training course was developed to prepare inspectors to perform intended joint inspections and to perform inspection according to the joint approach.
• Developing and delivering collaborating mechanisms designed to maximise the efficiency and effectiveness of resource deployment: Competent Authorities initiated a joint manufacturer inspection mechanism to reinforce market surveillance.

Work package 5: Clinical process and resource development

As part of their work package to improve clinical process and resource development, the Health Products Regulatory Authority (HPRA) in Ireland was coordinating the following:

• The identification and establishment of communication platforms and protocols: A pilot communication platform was developed to allow Competent Authorities the opportunity to discuss market surveillance issues in particular in the clinical arena that affect some or all European Competent Authorities in real time and provide a platform to discuss specific market surveillance issues in a confidential setting.
• Establish current practices and identify development and/or training needs in the evaluation of clinical data by authorities: Based on the findings from workshops and surveys, a training strategy was defined. Training material was developed to provide practical guidance on the assessment and review of clinical data as part of market surveillance activities.
• Identify and prioritise medical devices which require development of common specifications to define clinical criteria for safety and performance: Under the new proposals for a regulation on medical devices and in vitro diagnostic medical devices, common specifications will be developed addressing the clinical requirements for safety and performance. The work of the joint action helped identify the priorities for developing common specifications and helped inform the activities for implementing the new regulations.