Development of Overall Guidance on organization of PPA system

WP5: Development of Overall Guidance on organization of PPA system

This WP shall review the existing guidance relevant to PPA procedures including those that were, developed by previous projects (EUSTITE, VISTART, EUROTGPII and ECCTR); survey and evaluation of the existing PPA systems in force in the various Member States and, based on this, develop a set of best practice guidelines for PPA systems.

Description of work, lead partner and role of applicants
This WP will develop guidance on how a Preparation Process Authorisation programme should or could be organised. This WP will take advantage of the results of the VISTART Joint Action as far as analysis of existing procedures and drafting of authorisation principles for novel processes is concerned, as well as the outcomes of the EUSTITE, EUROGTPII and ECCTR projects, that should however be extended to the blood sector. In order to ensure comprehensive consideration and review of VISTART WP5B, EUROGTP II and ECCTR outputs and to ensure that development of the relevant technical annexes and guidelines, leaders of these projects/actions/WP will be involved in two devoted meetings. Revision of guidance for blood establishments will be as well ensured by adhoc subgroup Lessons learned from experience in the systems for authorisation of medicinal products and medical devices at national and EU level will be examined and compared with existing experience in the TCB fields.
The following activities will be included:
- Development, circulation and analysis of results of a questionnaire survey of MS to explore and have a
comprehensive picture of existing PPA systems – supplementing the VISTART WP5 Part B survey.
- Desk-based review of product authorisation systems in place in other relevant sectors (e.g. medicines, medical
- Organization of a multi-country workshop to further explore organizational and procedural models identified by the survey and to identify strengths, weaknesses and best practices.
- Development of general good practice guidelines for PPA – putting a system and Standard Operating Procedures in place at the Member State level, including a methodology to inform blood and tissue establishments (BE/TE) regarding those procedures.
The guidelines shall include:
• An overview of the single authorisation steps from the request submitted by a BE/TE to the release of
authorisation by CA
• Timing of application for PPA
• Definition of significant change in preparation process
• Terms for application (also building on the outcomes of VISTART WP6 - manual for inspections)
• Organisational models and mandates of the CAs responsible for the PPA
• Optimal composition of the assessing team in the CA (members' qualifications, background, use of external
experts etc.), definition of inspectors’ involvement,
• Definition of types of authorisation (e.g. full, conditional, temporary – taking into account the outcomes of
• Development of model template forms for PPA.

Expected Deliverables
D5.1 Extension of the outputs of previous projects, VISTART WP5B, EUROGTP II etc., to be applicable to blood establishments. (M7)
D5.2 Report on the outcome and conclusions of the survey, the desk-based review of PPA in other fields and the multi-country workshop (M15)
D5.3 Good practice guideline to authorisation on preparation processes in blood, tissues and cells (M32).

WP5 Leaders: Health Products Regulatory Authority (HPRA), Ireland - Organización Catalana de Trasplantes (OCATT), Spain


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