Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

  • India: Stability Data Required

    Nov 3, 2017

    In August, India’s Central Drugs Standard Control Organisation (CDSCO) notified all regional drug controllers that they must better enforce requirements for Indian manufacturers to submit quality data for nonpatent and proprietary medicines. CDSCO requires this data at the time of submission. Data should show that drug product is stable under storage conditions.

    Read more
  • TGA Responds to Increase in Clearance Docs

    Nov 3, 2017

    Due to the increase in GMP clearance applications, Australia’s Therapeutic Goods Administration (TGA) is implementing new process improvements. TGA estimates that 60% of clearance applications do not include all the supported evidence necessary to demonstrate that a manufacturing site meets requirements for supplying product to the Australian market. For all applications submitted on or after Sept. 26, TGA will conduct an application assessment once all outstanding fees have been paid. If the assessment finds certain information is missing, the agency will provide a written outline of the deficiencies noted.

    Applications submitted before Sept. 26 will have a one-time opportunity for sponsors to submit outstanding supporting information prior to assessment. TGA is also currently working on a revised GMP clearance guidance document and new Web-based Clearance Application Assistance Tool.

    Read more
  • Toolkit to Support Supply Chain

    Jul 5, 2017

    Recently, the U.S. FDA led a collaboration effort with participating Asia Pacific Economic Cooperation (APEC) regions to create a Supply Chain Security Toolkit for Medical Products. This toolkit contains training materials to educate regulators and industries in the Asia-Pacific region on best practices for ensuring the security of medical products in the supply chain. Training materials cover GMP, GDP, track and trace systems, surveillance/monitoring, etc. To further establish best practices in the global supply chain, APEC plans to also develop Training Centers of Excellence for Regulatory Science which will be responsible for furthering training on the toolkit.

    Read more
  • CFDA Releases GMP Inspection Data

    Jul 5, 2017

    In early June, the China FDA released its annual drug inspection report for 2016. The Agency conducted 431 total inspections, including GMP inspections. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA; however, the Agency only performed a fraction of these planned visits.

    Read more
  • China Publishes 5-Year Drug Plan

    Mar 10, 2017

    In late February, the China FDA published its five-year plan (2016–2020) on food and drug safety. The Agency intends to use the plan to set stricter standards for medical equipment and drug quality by enhancing supervision. The plan finalizes the quality consistency evaluation for 289 generic drugs, revises 3050 national drug standards and 500 medical equipment standards, and requires 100% rate of updates for periodic drug safety reports.

    Read more
  • New Inspection Process in China

    Jan 27, 2017

    The China Food and Drug Administration has committed to adopting a “double random” approach to inspections to improve oversight. This approach involves random selection of both the inspector and the organization or process being inspected.

    (Link in Chinese)

    Read more
  • Japan Seeks Collaborative API Effort

    Jan 27, 2017

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced in December plans to join the U.S. FDA and EMA to improve the GMP inspection process for sites producing APIs through a collaborative effort. Under this agreement, PMDA will be able to share information related to GMP inspections. This information would include inspection plans and results. This is part of PMDA’s International Strategy.

    Read more
  • Indian Regulator to Recruit More Inspectors

    Oct 3, 2016

    India’s Central Drug Standards Control Organization (CDSCO) recently announced plans to recruit more than 500 new drug inspectors in 2017 as part of a five-year plan to ensure the quality of drug product manufacturing within India and drug product manufactured for export. In addition, CDSCO hopes to train the recruiters effectively to ensure uniform GMP inspections.

    CDSCO recently finished recruiting 147 drug inspectors as part of a push to enhance cGMP inspections of manufacturing units.

    Read more
  • EU/Chinese Work Groups Meet on Anticounterfeiting

    May 5, 2016

    The European Union and China Working Group on Pharmaceuticals recently met to discuss drug evaluation and approval procedure reform, anticounterfeiting legislation and management of online pharmacies. This comes as part of the Consultation and Cooperation Mechanism agreement signed in 2013, which states the China Food and Drug Administration and the European Commission will meet more regularly for constructive dialogue on pharmaceutical laws and regulations.

    Read more
  • U.S. FDA, Provincial Chinese FDAs Strengthen Cooperation

    May 5, 2016

    Staff from the FDA’s China Office recently met with provincial FDA regulators, industry and academia in China’s Yangtze River Delta region to discuss strengthening partnerships, sharing information and building the foundation for future cooperative engagement.

    Read more
  • Chinese Pharmacopoeia Now in Effect

    Mar 10, 2016

    Dec. 1, 2015, the China Food and Drug Administration (CFDA) announced that the 2015 edition of the Chinese Pharmacopoeia (ChP) has gone into effect. The new edition will drive the overall improvement of drug quality and play a significant role in ensuring drug safety and effectiveness for the public by requiring any drug product and drug ingredient intended for marketing in China to comply with ChP 2015 requirements or use ingredients that comply with ChP 2015 requirements.

    Read more
  • TGA Joins ICH

    Feb 10, 2016

    Australia’s Therapeutic Goods Administration (TGA) has joined ICH as its latest observer, allowing TGA representatives to attend ICH Assembly meetings and participate in ICH activities.

    Read more
  • China, U.S. to Combat Drug Counterfeiting

    Jan 8, 2016

    At the China-U.S. Joint Commission on Commerce and Trade in Guangzhou, China in late November, both countries agreed to enhance cooperation on efforts to prevent the selling of counterfeit drugs online.

    The U.S. and China also made efforts to work together on drug and medical device registration approval and greater regulation of clinical trials.

    Read more
  • MHRA Signs MoH with Indian Counterpart

    Nov 19, 2015

    On Oct. 5, the United Kingdom’s Medicines and Healthcare products regulatory agency, MHRA, recently signed a Memorandum of Understanding with India’s Central Drug Standard Control Organization (CDSCO) as part of an agreement to increase collaboration between the two countries on public safety.

    This is the first Memorandum of Understanding signed with CDSCO. Both agencies hope this agreement facilitates expanded exchange of information and opportunities for collaboration.

    Read more
  • China FDA Releases Device GMPs

    Nov 12, 2015

    The China FDA recently released four guidelines promoting GMPs for medical devices. These guidelines strengthen regulatory oversight of medical device manufacturing in the country and cover onsite inspections of sterile medical devices, implantable devices and in vitro diagnosis reagents.

    Read more
  • New Zealand Seeks Updated Drug, Device Regs

    Oct 6, 2015

    In mid-September, New Zealand announced plans to introduce a new bill in 2016 that would align the country’s medical device and drug product regulations with global standards. In addition, the new regulation would cover cell and tissue therapies, which are currently not regulated in the country. Regulators hope the new regulation will be flexible enough to ensure effective oversight while also being efficient in light of technological advances in therapeutic products.

    This development follows the end of efforts to create a joint regulatory body between New Zealand and Australia.

    Read more
  • Malaysian MDA Extends Fast-Track Device Registration Period

    Jul 8, 2015
    Malaysia’s Medical Device Authority (MDA) has extended the deadline for temporary fast-track device registrations to June 30, 2016.
    Read more
  • TGA Releases Two-Part Batch Release Guidance

    Mar 11, 2015
    Australia’s TGA recently released a guidance on batch release containing two parts. The first offers guidance on general requirements and the other provides examples of how these general requirements can be met. This latter part is currently being developed.
    Read more
  • India Plans to Formalize Presubmission Meetings

    Feb 2, 2015

    India’s Central Drugs Standard Control Organization (CDSCO) laid out plans to formalize presubmission meetings in a Jan. 28 notice. Presubmission meetings allow companies and regulators an opportunity to review potential submissions and ensure they conform to regulatory requirements. By formalizing these meetings, CDSCO is aligning itself with practices of other global regulators.

    Read more
  • Chinese FDA Releases First GSPs for Devices

    Jan 29, 2015

    The Chinese Food and Drug Administration recently issued the country’s first GSP regulations for all Class 1, 2, and 3 medical device distributors. Third-party logistics providers also fall under these new regulations, which establish minimum standards for procurement, storage, transportation and postsale services and require distributors to implement quality management systems for all aspects of the delivery process.

    These new GSPs became effective Dec. 12.
    Read more
  • Revised CFDA GMPs Emphasize Quality Management Systems

    Jan 29, 2015

    China’s Food and Drug Administration recently revised its GMPs for medical devices, updating the regulations to require manufacturers to setup quality management systems adhering to the GMPs.

    These revised GMPs become effective March 1.

    Read more
  • Australia and New Zealand Agree to Shut Down Joint Regulatory Body

    Dec 1, 2014

    The Australian and New Zealand governments confirmed in late November that both governments will cease efforts to establish the joint therapeutic products regulatory body, or Australia New Zealand Therapeutic Products Agency (ANZTPA), following an assessment of the costs and benefits for both countries.

    Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe), however, plan to continue exploring other harmonization activities between both regulatory authorities, including the development of a new agreement on information sharing as well as a formalized mutual recognition of GMP audits.

    Read more
  • Australian Authorities Adopt Real-Time Release and Nonsterile Analysis Guidelines

    Aug 14, 2014

    Australia’s Therapeutic Goods Administration (TGA) recently adopted a number of EU/ICH guidelines, including EMA’s guideline on real-time release testing and ICH Q4B annexes on microbiological analysis of nonsterile products.

    These guidelines became effective Aug. 1.

    Read more
  • Taiwan FDA Signs Confidentiality Agreement with EDQM

    Jul 21, 2014
    In late May, the Taiwan Food and Drug Administration signed a confidentiality agreement with the European Directorate for the Quality of Medicines and Healthcare (EDQM), the authority behind the European Pharmacopoeia.
    Read more
  • Australia Accepted as EDQM Assessor

    Jun 26, 2014
    In May, EDQM accepted Australia’s Therapeutic Goods Administration (TGA) as an assessor in EDQM’s procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia, also known as CEPs. Assessors with TGA will participate in the scientific assessment of applications submitted to obtain a CEP. This process involves assessing whether or not monographs control for chemical purity, microbiological quality and, if relevant, risk of transmissible spongiform encephalopathy (TSE) transmission.    
    Read more
  • Australia’s TGA Adopts EU/ICH Guidelines

    Jun 4, 2013

    Effective June 1, the Australian Therapeutic Goods Administration (TGA) has adopted four EU/ICH guidelines. These include EMA’s guidelines on plasma-derived products, active substance master file procedures, and bioanalytical method validation in addition to the ICH Q3 (R5) guideline on residual solvents.

    The adoption of these guidelines followed consultations between TGA and members of industry.

    Read more
  • China FDA Finalizes Reorganization

    Jun 3, 2013

    The consolidation of the China Food and Drug Administration, formerly the State Food and Drug Administration, has been finalized.

    New pharma-related duties of the CFDA will include pharmacopoeia codification, drug manufacturing certification, GMP certification, drug supply certification and GSP certification. Local FDAs will handle reregistration of drugs, changing approval of class III medical device registrations and contract manufacturing applications.

    Read more
  • Indian Pharmacopoeia Releases Compliance Guide

    Jan 3, 2013

    Earlier this year, the Indian Pharmacopoeia Commission (IPC) released a compliance guide with a number of topics, ranging from good laboratory practices to stability testing as well as water quality regulations. This guide is the first of its kind for IPC and was written with both manufacturers and regulators in mind. IPC hopes the manual will ensure that manufacturers are better able to comply with regulatory and testing requirements.

    Read more