• China to Require Registration of all Clinical Trials, Bioequivalence Studies

    China's Food and Drug Administration (CFDA) is requiring clinical trial sponsors to register all trials (Phases I, II, III, IV) and bioequivalence testing, according to World Health Organization (WHO) requirements posted online . The 6 September 2013 bulletin mandates that the required information be posted within one month after pre-registration of the trial, followed by an update within one year. The trial's approval will be revoked if the registration requiremen...
  • New Medicines Trademark Policy Coming in Brazil

    Brazil's National Agency for Sanitary Surveillance (Anvisa) is hosting a public hearing on 24 September 2013 to discuss the criteria that have been proposed for the creation of trade names for medicines in Brazil. The agency's proposal has been the subject of public consultation since it was first proposed in 2010 (CP No. 72/2010) and is intended to minimize or eliminate the possibility of misinterpretation, error or confusion as to the source, origin, nature, composi...
  • Indian Report Calls for Reforms to CDSCO, Drug Regulations

    The Expert Committee convened by India's Central Drugs Standard Control Organization (CDSCO) has issued a report  with 25 regulatory reform recommendations on "Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs."  Although the report acknowledges the local regulatory authority of India's states, it proposes the establishment of a Central Accreditation Council (CAC) at the national level for the accreditation of clinical tria...
  • Chinese Provinces Told to Advance Regulatory Science and Technology

    China's Food and Drug Administration (CFDA) has issued a notice to the country's provinces and municipalities instructing them to prioritize scientific and technological innovation in order to bolster food and drug regulation in keeping with the Party's Long-term Scientific and Technological Development Plan (2006-2020).  In accordance with the requirements of the State Council on institutional reform and transformation, the notice instructs local food and drug r...
  • Brazil's Anvisa Renews Focus on Nanotechnology

    Brazil's National Agency for Sanitary Surveillance (Anvisa) renewed its cooperation agreement on 9 September 2013 with the country's National Council for Scientific and Technological Development (CNPq).  The renewal particularly foresees cooperative research on the use of nanotechnology in products of interest to health and whether there is a need for regulation targeting such products.  The objective is to fill the existing gaps in scientific technolog...
  • India Establishes Procedures for Importing Pharmaceuticals for Personal Use

    India's Central Drugs Standard Control Organization (CDSCO) has established procedures for the import of small quantity of drugs for personal use "for the needy patients of India." Generally, an individual can import a quantity not to exceed 100 "average doses" as long as the drug is part of the "bona fide" personal luggage of the individual and is declared to Customs.  However in "exceptional cases," an individual may import "a large quantity" for personal use ...
  • Russia Developing New Guidance for IVDs

    Russia's Federal Service on Healthcare Surveillance (Roszdravnadzor) has launched a public consultation to develop new guidelines for the evaluation of the quality, effectiveness and safety of in-vitro diagnostics products.  According to the agency, the guidance will be prepared under the direction of the Ministry of Health's Head Specialist for Clinical Laboratory Diagnostics, Anatolia Kochetova, with the assistance of expert organizations and leading experts in...
  • India Requires Disclosure of Sponsor/Investigator Payments

    Applications for approval of clinical trials in India must now include information concerning the agreement as to the payments that will be made by the sponsor to the trial investigator, according to a notice issued by India's Central Drugs Standard Control Organization (CDSCO) on 30 August 2013. India's Good Clinical Practices (GCP) regulations require the sponsor to conclude a contract with the trial investigator or institution, which must define the relationship bet...
  • Bill Creating Indian Central Drugs Authority Introduced

    Legislation has been introduced in India that would establish a new Central Drugs Authority (CDA) with overarching power to regulated drugs, devices and cosmetics. The Drugs and Cosmetics (Amendment) Bill of 2013 was introduced on 30 August 2013 in the Rajya Sabha (Upper House of Indian Parliament) by Health and Family Welfare Minister Ghulam Nabi Azad and would replace the Drugs and Cosmetics Act of 1940. The Central Drugs Authority would be composed of 19 members...
  • CFDA Expands Bilateral Agreements With WHO, European Countries

    China's FDA recently expanded bilateral cooperation agreements with two European countries and the World Health Organization (WHO) within a one-week timeframe. On 22 August 2013, Commissioner Zhang Yong met with WHO Director-General Margaret Chan on the ongoing bilateral cooperation on food safety and drug regulatory issues.  On 20 August 2013, Commissioner Yong met with the Czech Minister of Health and reached agreement on further cooperation and exchanges o...
  • Brazilian Good Practices Certification Process Simplified

    Brazil's National Agency for Sanitary Surveillance (Anvisa) published a  new resolution  (RDC No. 39/2013) on 16 August 2013 that replaces ten previous resolutions with a single administrative standard governing Good Practices Certification (GPC) and the definition of criteria for automatic renewal of such Certificates for medicines and medical devices, as well as cosmetics.   The new standard simplifies the contents of certificates of Good Manufactur...
  • India’s CDSCO Issues Compliance Deadline to Fixed Dose Combination Manufacturers

    India's Central Drugs Standard Control Organization (CDSCO) issued a notice on 1 July 2013 to State Drug Controllers ordering all manufacturers of new fixed dose combination (FDC) products licensed locally before October 2012 without CDSCO permission to submit safety and efficacy data prior to 30 August 2013. Manufacturers that fail to submit the data by the deadline run the risk of having their products banned from the market, CDSCO said. The notification is the secon...