Table 2.

Measures to strengthen the procedure: period 1987–2013.

Characteristic	1987	1989	1997	2002	2005	2010
Measures to improve the procedure
Cost of inspection/site visit/site audit paid by manufacturer
Inclusion of confidentiality and non-conflict of interest clauses
Provision for evaluation of products formulated and filled by a manufacturer purchasing bulk material from a prequalified source
Establishes criteria to consider waiving the site visit
Establishes a funding mechanism based on fees for service to the manufacturers
Validity of the prequalification two years
Validity of prequalification is between two and five years depending on performance
Prequalification and reassessment scope and frequency based on risk analysis
Includes special considerations for fast-track procedure in emergency situation or case of acute shortage of vaccine
Strict timelines for evaluation (target 12 months without counting time taken by manufacturer to provide responses to questions or corrective actions)
Includes special considerations for accepting submissions before license is granted
Includes special considerations for accepting submissions of vaccines that have been licensed in countries different from that of manufacturer
Introduces a streamlined procedure for evaluation of vaccines regulated by stringent regulatory authorities and defines basis for selection of the authorities. Evaluation process based on review of reports provided by the NRA
Introduces a streamlined procedure for evaluation of vaccines which were granted a positive Scientific Opinion by the CHMP (Art. 58)
Special considerations for vaccines produced in multiple sites or different countries
Improved communication and transparency through upgraded web list and other published documents (rationale for PQ, statements on investigation of AEFIs and complaints, points to consider for manufacturers)