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    Asia Regulatory Roundup: India Creates Compensation Application Form for People Affected by J&J Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Pushes Ahead With Efficacy Claimer Labels Despite Mixed Response   Australia’s Therapeutic Goods Administration (TGA) is going ahead with plans to allow the addition of an efficacy claim to the labels of certain nonprescription products. TGA committed to implementing the idea despite it receiving a frosty reception from producers of over-the-counter (OTC) medicin...
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    EU Regulatory Roundup: EMA Starts Revising Guidance on Clinical Trials in Neonates

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Starts Revising Guidance on Clinical Trials in Neonates   The European Medicines Agency (EMA) has published a draft concept paper on the investigation of medicinal products in neonates. EMA is revising its stance on testing drugs in newborn babies after interactions with sponsors identified shortcomings in the guidance it published on the topic in 2010.   In...
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    Asia Regulatory Roundup: After Legal Fight, India Bans 328 Fixed-Dose Combinations

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   After Legal Fight, India Bans 328 Fixed-Dose Combinations   India has banned 328 fixed-dose combinations (FDCs) with immediate effect, furthering its two-year fight to get the products off the market. The FDC ban follows a ruling that there is no therapeutic justification for the combinations.   Officials first targeted FDCs in March 2016. At that time, the Indi...
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    EU Regulatory Roundup: EC Advises Sponsors on Brexit’s Impact on Trials

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   European Commission Advises Sponsors on the Effect of Brexit on Clinical Trials   The European Commission has advised sponsors on how Brexit will affect clinical trials. The notice picks out the supply of investigational products, need to have a representative in the European Union and the submission of clinical trial information as the key points to consider ahead ...
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    Asia Regulatory Roundup: India Shares Draft Legislation on Regulation of Online Medicine Sales

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Shares Draft Legislation on Regulation of Online Medicine Sales   India has released draft legislation covering online pharmacies. The text sets out how organizations can receive clearance to operate as e-pharmacies and the rules they must follow to maintain their authorizations.   The question of how to facilitate a safe online trade in medicines has occup...
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    EU Regulatory Roundup: ENVI Calls for Temporary Increase in EMA Budget to Mitigate Effects of Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   ENVI Calls for Temporary Increase in EMA Budget to Mitigate Effects of Brexit   The European Parliament’s health committee has called for an increase to the region’s regulatory budget and staffing levels. Members of the committee think the European Medicines Agency (EMA) needs the extra resources to maintain its normal level of service while relocating to Amsterdam....
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    Asia Regulatory Roundup: CNDA Sends Team to Oversee Regional Regulatory Investigation Into Fosun Unit

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CNDA Sends Team to Oversee Regional Regulatory Investigation Into Fosun Unit   The China National Drug Administration (CNDA) has sent a team to oversee an investigation into a subsidiary of Shanghai Fosun Pharmaceutical. CNDA took the action after Chongqing Food and Drug Administration (FDA) performed a surprise inspection of Fosun’s Chongqing Pharmaceutical Research...
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    EU Regulatory Roundup: UK Clears People Previously Treated With Advanced Therapies to Participate in Trials

    UK Clears People Previously Treated With Advanced Therapies to Participate in Trials   The United Kingdom has revised its stance on the inclusion of people treated with advanced therapy medicinal products (ATMPs) in clinical trials. Prior treatment with a cell therapy or other ATMP used to prohibit a patient from participating in clinical trials but the UK has now relaxed its position.   UK officials changed the policy in light of the limited treatment options av...
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    Asia Regulatory Roundup: China Seeks Feedback on Plans for Drug Traceability and Unique Device Identifiers

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Seeks Feedback on Plans for Drug Traceability and Unique Device Identifiers   The China National Drug Administration (CNDA) has posted draft guidance on the construction of IT systems capable of tracking drugs as they move through the supply chain. CNDA posted the guidance on the same day as it released a draft document setting out its position on unique device...
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    EU Regulatory Roundup: EMA Calls for Experts to Help get Amsterdam Headquarters Ready

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Floats Changes to Guideline on Clinical Development of Epilepsy Drugs   The European Medicines Agency (EMA) has proposed revisions to its guideline on the development of medicines to treat epileptic disorders. EMA embarked on the update to encourage sponsors to run clinical development programs that generate safety and efficacy data in a variety of seizure types. ...
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    Asia Regulatory Roundup: China Fires Top Regulatory Officials Over Vaccine Oversight Failures

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Fires Top Regulatory Officials Over Vaccine Oversight Failures   The Chinese authorities have ousted senior regulatory officials for their roles in the vaccine scandal engulfing the country. Ding Jianhua, who led two departments at the agency, was dismissed along with five other senior officials.   In explaining the dismissals, authorities accused the Chine...
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    EU Regulatory Roundup: EMA Creates Simplified Transfer Process for Some MAHs Affected by Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Creates Simplified Transfer Process for Some MAHs Affected by Brexit   The European Medicines Agency (EMA) has created a simplified process for transferring marketing authorizations in response to Brexit. The process is open to companies that want to move marketing authorizations between organizations registered under the same EudraVigilance headquarter profil...