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Navigating a successful entry into the Chinese pharmaceutical market
30 - January 2023, Princeton, NJ - Martin E. Zuzulo, Managing Director, Americas at Widler & Schiemann, LLC, outlines the challenges and opportunities for US companies entering the Chinese market.
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Expansion of Scope of Temporary Authorizations
1 December 2022 – the Swissmedic published guidance on temporary authorizations.
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Updated Swissmedic / Swissethics Position Paper on Decentralized Clinical Trials (DCTs) of Medicinal Products
22 December 2022 – the Swissmedic updated the position paper on decentralized clinical trials of medicinal products.
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Clarification of Terminology for Combination Products (Medicinal Products with a Medical Device Component)
15 December 2022 – the Swissmedic published guidance on clarification of terminology for combination products.
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Register Medical Devices to Place on the Market
6 December 2022 – the MHRA published updated guidance on the registration of medical devices.
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More Articles...

  1. Medicines: Apply for a Parallel Import License
  2. Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
  3. Statistical Approaches to Establishing Bioequivalence
  4. ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
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