Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system." With the intention of addressing the criticisms of the current system from a public consultation on  the regulatory framework for advertising therapeutics  in November 2016, the decision means all complaints...

Australia’s Therapeutic Goods Administration (TGA) on Monday released a proposal to allow for the use of devices that have received marketing approvals from select foreign authorities. TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes Electronic Platform to Monitor Drug Supply Chain The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India. India’s Mini...

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 ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Posts Guide to Online Application Form for High-Risk IVDs TGA has released a guide to using its online application form for Class 4 in-house in vitro diagnostic (IVD) devices. In keeping with recent guides created by TGA, the IVD document is a comprehensive walkthrough of the process of applying online for devices that fall into the highest-risk category. Class 4 IV...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Orders Manufacturers to Assess Their Compliance with GMPs, GLPs The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry out the self-assessment, award themselves a quality rating and submit the resulting report to the relev...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...

Australia’s Therapeutic Goods Administration (TGA) is calling attention to medical device battery issues, particularly for implantable devices, and saying manufacturers and health facilities should adopt procedures to reduce risk. A battery-related problem was listed as a potential contributing factor in more than 50 adverse event reports over the past 10 years involving deaths or serious injuries, the Australian regulator said, noting a range of safety alerts over the p...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Pushes to End Regional Variation in Strength of Clinical Trial Oversight The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality. CFDA began its clam...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Releases Medical Device Adverse Event Reporting Form for Consultation The Indian Pharmacopoeia Commission (IPC) has released a medical device adverse event reporting form for consultation. IPC has drafted the template as part of the drive in India to establish a materiovigilance program to monitor the safety of medical devices. Once the form is finalized, filers o...

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled new guidance on the eligibility requirements for medical device and in vitro diagnostic (IVD) companies looking to reduce assessment fees by as much as 70%. The reduction in fees could save industry a significant amount of money as, according to the new fees published in July by TGA, conformity and audit assessment fees can range from about $4000 to more than $50,000, depending on the type of assessm...

AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries. As it stands, companies pursuing the approval of medical de...