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  • RoundupsRoundups

    Asia Regulatory Roundup: Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Extends Timelines for Reporting Medical Device Adverse Events   The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given companies more time to report adverse events involving their medical devices.   Under the old rules, manufacturers of medical devices had seven calendar days to report incidents of actual or potential death...
  • RoundupsRoundups

    Asia Regulatory Roundup: Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs   Australia’s Therapeutic Goods Administration (TGA) has aligned its requirements for sartan medicines with those adopted in Europe. The action coincided with news from Singapore about the presence of N-nitrosodimethylamine (NDMA), one of the key sartan impurities, in GlaxoSmithKline’s Z...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Considers Some DTC Drug Ads (4 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Changes to Oversight of Low-Risk OTC Products The Therapeutic Goods Administration (TGA) of Australia has put forward proposed changes to the regulation of low-risk products for consultation. TGA is seeking feedback on whether it should free some over-the-counter (OTC) medicines from the need to go through premarket assessments. Currently, TGA c...
  • Feature ArticlesFeature Articles

    Drug Regulatory Authority of Pakistan: Organizational Structure, Functions and Future Challenges

    This article discusses the development of a more effective pharmaceutical regulatory environment in Pakistan through the establishment of a regulatory agency designed to address current good manufacturing practices and quality management systems for drug production to improve the availability, accessibility and affordability of drugs. Introduction and Background As regulatory bodies continue to stress the need for standardizing current Good Manufacturing Practices (cG...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Medical Device Rules, Marking Long-Sought Split From Drug Regulation India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector. Until now, a lack of dedicated regulations covering the majori...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Guidance on Security of Connected Devices (31 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Security of Connected Medical Devices China Food and Drug Administration (CFDA) has released guidance on the security of connected medical devices. The guidance details the factors companies should consider when seeking to register a device with data storage and exchange capabilities for sale in China. CFDA is aiming the guidance at Class II and...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CDSCO Creates Induction Program to Raise Standards at Inspectorate The Central Drugs Standard Control Organization (CDSCO) has set up an induction program to train assistant drug inspectors. A three-month training program, in which CDSCO will cover the regulatory framework in India and other topics, is the centerpiece of the induction strategy. CDSCO has introduced ...