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  • RoundupsRoundups

    Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Plan to List Excipients in Drug Products Online   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to list the excipients in medicines online. TGA is considering enforcing the change to give consumers access to information about the products they consume.   Today, the public version of the Australian Register f...
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    Asia Regulatory Roundup: India Forms Medical Device Technical Advisory Group to Help CDSCO

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Reveals Recently Passed Order Faced Strong Industry Opposition   Australia’s Therapeutic Goods Administration (TGA) has revealed that parts of the medicines industry objected strongly to its recently adopted standard for tablets and capsules. The legislation came into effect in March despite big pharma trade group Medicines Australia arguing that, “It is unclear ...
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    Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Fixes Price of Orthopedic Knee Implants, Tells Manufacturers to Maintain Supply India has capped the price of orthopedic knee implants. The imposition of ceiling prices continues the National Pharmaceutical Pricing Authority’s (NPPA) push to control the cost of medical devices sold in India. Months after setting limits on the prices of coronary stents, NPPA has ...
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    Asia Regulatory Roundup: India’s NPPA Withdraws List of Pricing Rule Violators (30 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Withdraws Lists of Alleged Violators of Pricing Rules After Industry Pushback India’s National Pharmaceutical Pricing Authority (NPPA) has withdrawn lists of drugmakers it thinks have violated its rules. NPPA published three such lists in recent months to get drug manufacturers including Abbott, Novartis and Sanofi to provide it with information, causing "discomfo...
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    Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. NPPA included the top pharmaceutical firms on a list of companies that allegedly introduced drugs without seeking price appro...
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    Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain br...
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    Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pfizer Asks TGA to Rethink Proposed Timeline for Biological Adverse Event Reporting Pfizer has asked the Therapeutic Goods Administration (TGA) of Australia to reconsider proposed timelines for reporting adverse events related to biologicals. The drugmaker wants TGA to mirror the reporting requirements for other medicines, rather than introduce the tighter timelines i...
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    Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Steps up Initial GMP Inspections After Adopting Risk-Based Approach The Therapeutic Goods Administration (TGA) of Australia has increased initial inspections of drug manufacturing plants at home and overseas. TGA reported double-digit increases in the number of initial inspections of local and foreign firms in the back half of last year following the introduction ...
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    Asia Regulatory Roundup: Quality Issues Push TGA to Seek New Source for Angina Drugs (2 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Looks for new Sources of Angina Drug After Quality Issue Threatens Supply The Therapeutic Goods Administration (TGA) of Australia has started talking to manufacturers about establishing an alternative source of glyceryl trinitrate (GTN) tablets. Officials initiated the search to minimize the impact of quality problems at Arrow Pharmaceuticals, the sole supplier o...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
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    Asia Regulatory Roundup: China FDA Seeks Comment on Generic Drug Quality Guidance (24 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. FIA Remands 4 Senior Pakistani Officials in Fraudulent Drug Approval Case The Federal Investigation Agency (FIA) has remanded four senior officials at the Drug Regulatory Authority of Pakistan (DRAP). FIA took the action after investigating the alleged issuance of a fake drug registration letter for a treatment for premature ejaculation. DRAP’s deputy director general o...
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    Asia Regulatory Roundup: China Looks to Revamp Drug Approval Process (3 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Proposes Drug Approval Reforms to Encourage Innovation Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research. As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincen...