1 min read

Stringent Regulatory Authorities (SRAs) are national drug Regulatory bodies listed and recognized by the World health Organization (WHO), who are responsible for applying rigorous standards when reviewing and approving drugs/vaccines. The stringent standards set by SRAs focus on the following three (03) key aspects:

  • Quality: SRAs ensure that drugs are manufactured according to established quality control procedures to guarantee their purity, potency, and consistency.
  • Safety: SRAs mandate extensive clinical trials to assess potential risks and side effects of new drugs before they are marketed.
  • Efficacy: SRAs meticulously evaluate the data demonstrating a drug’s efficacy in treating the intended condition(s).

How are SRAs Identified?

SRAs are identified based on two (02) main criteria, which are:

  • Membership in the International Council for Harmonisation (ICH): The ICH brings together Regulatory authorities from the European Union (EU), United States (US), and Japan to establish a unified approach for pharmaceutical development and registration.
  • WHO Designation: The WHO maintains a list of SRAs, based on their evaluation of the particular authority’s procedures and adherence to international quality standards.

The Importance of SRAs in the Pharmaceutical Industry

SRAs play a critical role in the pharmaceutical industry, as their regulations help:

  • Minimize Health Risks: Rigorous testing procedures adopted by SRAs reduce the chances of unsafe or ineffective products reaching the market.
  • Promote Innovation: Clear, consistent regulations set by SRAs provide a framework for pharmaceutical companies to develop new and effective treatments.
  • Facilitating Global Access: Approval by an SRA can streamline the process for a drug to be marketed in other countries with similar Regulatory requirements.

Thus, SRAs are essential for building a pharmaceutical landscape that prioritizes patient safety while fostering innovation. Speak to our expert today to learn how Freyr can help you seamlessly navigate the realm of SRAs.