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News & Press: Regulatory Updates

PHSS Apr 2016 Regulatory Update :Pot presence of mutagenic alkyl sulfonates; SFDA requires Generics

13 April 2016  
Posted by: Tamsin Marshall
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PHSS April Regulatory Update 

 

The topics covered in this edition of the “Update” include:

 

Europe

  • Potential presence of mutagenic alkyl sulfonates in active substances

USA

  • Environmental Assessment: Q&A Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity
  • Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act
  • Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
  • Labeling for Biosimilar Products
  • Recommendations to reduce the risk of Zika virus transmission by human cell and tissue products

International

Canada

  • Post-Notice of Compliance (NOC) Changes

China

  • SFDA requires Generics to obtain brand-name drug quality

Documents

  • The Responsible Person for GDP – Code of Practice

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