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  • Regulatory NewsRegulatory News

    India Looks to Further Ease Process of Running Clinical Trials

    India’s Central Drugs Standard Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there. In two joint circulars – from CDSCO, the Directorate General of Health Services, the Ministry of Health and Family Welfare and signed by G.N. Singh, Drugs Controller General –  India will no longer stop trial investigators from conducting more than three trials at a time, and India will revise its requireme...
  • Regulatory NewsRegulatory News

    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Updates Process for Closeout of On-Site GMP Inspections Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection r...
  • Regulatory NewsRegulatory News

    FDA to Pharma Companies: Indian CRO’s Clinical and Bioanalytical Studies are Unacceptable

    Another day, another issue with data integrity. This time, however, the US Food and Drug Administration (FDA) is taking the issue one step further and notifying sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that clinical and bioanalytical studies conducted by Bangalore, India-based contract research organization (CRO) Semler Research are not acceptable as a result of data integrity concerns and need to be repeated. Following its r...
  • Regulatory NewsRegulatory News

    India Releases New Biosimilars Guidance

    India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies. The new document is a slight tweak of previous guidance issued in 2012 , but includes several important changes that are now up for discussion through 30 April. India's biosimilars market currently includes ei...
  • Regulatory NewsRegulatory News

    India's Supreme Court Denies Petitions Challenging CDSCO

    • 11 March 2016
    Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to hear two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates. Thakur told Focus that the petitions “challenge how CDSCO works and the commitments it makes” to keeping subst...
  • Regulatory NewsRegulatory News

    FDA Begins Training Hundreds of Indian Regulators

    The push to get India’s pharmaceutical and medical device regulators up to speed with international norms and the US Food and Drug Administration’s (FDA) regulations is progressing with new cooperative training sessions. Recently, in Ahmedabad and Bengaluru, India, FDA officials conducted training sessions for about 200 Indian regulators, the majority of which were new inspectors, representing the Central Drugs Standards Control Organization (CDSCO) and some state drug c...
  • Feature ArticlesFeature Articles

    FDA's New Office of Pharmaceutical Quality

    The Center for Drug Evaluation and Research Office of Pharmaceutical Quality (OPQ) was launched in 2015. This article examines FDA's reasons for implementing a major change to oversight of manufacturing quality and the implications for consumers, sponsors and regulatory professionals. The Future of Quality FDA has been and continues to be committed to assuring quality (i.e., safety and efficacy) medicines are available to the American public. FDA implemented quality o...
  • Regulatory NewsRegulatory News

    FDA Promotional Enforcement Actions Hit Record Low in 2015

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations. While OPDP has seen a general downward trend in issuing action letters in recent years, 2015 marks the first time the office has issued fewer than 10 letters in a single year. In 2014, OPDP issued 11 letters, though it would later go on to retract one letter to Pacira Pharmaceuticals and li...
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    Asia Regulatory Roundup: India Pushes Back Track and Trace Deadline Again (12 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Moves Back Deadline for Implementation of Track and Trace India has pushed back the deadline by which manufacturers must comply with aspects of its system to track and trace drug exports. Having originally set a deadline of July 2015, the government has now once again delayed the date on which the export monitoring system must be implemented. The Directorate Genera...
  • Regulatory NewsRegulatory News

    FDA Warns Two Cadila Manufacturing Plants in India

    Just before the end of 2015, the US Food and Drug Administration (FDA) warned two Indian pharmaceutical manufacturing facilities from Cadila Healthcare for major good manufacturing practice (GMP) violations. The warning letter (not to be confused with the warning letter for another Indian manufacturer that goes by the name of Cadila Pharmaceuticals) caps a year of increased scrutiny for Indian drug manufacturers from FDA. Letter Details In particular, FDA found tha...