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) | ||||||