By Published On: March 3rd, 2020Categories: News

Post-Authoirsarion Safety Studies (PASS) – Categories and Considerations

You are a CRO and (1) you’ve been asked to submit a proposal to conduct a client’s post-authorisation safety study (PASS), or (2) you’ve won the work and now need to deliver the goods.

Key Consideration #1 = Is the proposed study a Category 1, 2 or 3 PASS?

  • Why is this important?

> Category 1 and 2 PASS are imposed by the EMA as a condition of the marketing authorisation for the medicinal product.  This ‘imposition’ comes with additional and specific regulatory requirements, compared to Category 3/ voluntary PASS (refer to Figure 1 and Table 1)

  • How do I find out?

> The quickest way is to head to the EMAs website and search for the products European Public Assessment Report (EPAR).  Check Annex II.D (Category 1 PASS) and Annex II.E (Category 2 PASS) of the Marketing Authorisation/ European Public Assessment Report (for centrally authorized products),  If the PASS isn’t listed there then it’s a Category 3 PASS (refer to Table 2)

Key Consideration #2 = What are the country-specific regulatory requirements for your PASS?

  • The country-specific requirements will (usually) depend on the Category of the PASS and the study design (e.g., secondary or primary data, +/- biosamples, collection of genetic data etc) (refer to Figure 1)
  • Some companies have consolidated this information and provide access for a fee (e.g., CHCUK). Otherwise, it’s a case of assessing and consolidating the applicable regulations, guidelines and best practices for each country
  • For Category 1 and 2 PASS, these country-specific requirements are ADDITIONAL to the regulatory requirements imposed by the EMA through Regulation EC/726/2004, Regulation EC/520/2012 and Directive 2001/83/EC


>>>Download a PDF Copy of our ‘PASS Categories and Considerations‘<<<

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