Global expedited Regulatory Pathways

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Global expedited Regulatory Pathways

Global expedited regulatory pathways are processes crafted to speed up new drug approval and availability across different countries. These include drugs, vaccines, and medical devices. These pathways aim to bring the new drugs  as fast as possible by fastening the regulatory pathways with no compromise on the safety and efficacy of the new drugs.

Here is a list of Global expedited regulatory Pathways

UK

  1. Early Access to Medicine Scheme (EAMS) PIM designation.

Canada

  1. Conditional approval (Notice of compliance with conditions)
  2. Priority Approval.

Australia

  1. Priority review pathway.
  2. Provisional Approval Pathway.

China

  1. Priority Review
  2. Conditional Approval
  3. Break through Therapy Designation

Japan

  1. Priority Review
  2. Conditional and term related approval
  3. Conditional approval for drugs
  4. Sakigake Forerunners designation

US

  1. Accelerated approval
  2. Priority review
  3. Fast Track
  4. Break through therapy designation
  5. Regenerative medicine advanced therapy designation ( RMAT )

European Union:

  1. Accelerated assessment
  2. Marketing Authorization under exceptional conditions
  3. Conditional marketing authorization
  4. Adaptive Pathway Approach.

These are some of the global expedited regulatory pathways.

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