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11

Mar

EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection

  • A final version of the draft pharma reform package has been published, clarifying changes that the pharma industry can expect once the legal package enters into force.
  • The legislation, which comprises a new regulation and directive, will replace the existing framework that has been in place for more than two decades.
  • The pharma reform package introduces, among many other things, changes to market protection for new drugs in the EU.

     

23

Apr

Top Drugs at Risk of Supply Shortages

Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...

23

Apr

Regulatory considerations for pharmaceutical excipient selection

The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...

21

Apr

TGA clarifies therapeutic goods are unaffected by chemical production and import ban

TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...

20

Apr

US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics

FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...

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