Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Finds Major Faults During Every Pharmacovigilance Inspection in First Year of Scheme
Australia’s Therapeutic Goods Administration (TGA) found at least four major deficiencies in every pharmacovigilance inspection it performed last year. The prevalence of major findings suggests the industry is still getting used to the requirements.
TGA began its pharmacovigilance inspection program in September 2017 and conducted its first site visit the following January. The January inspection was the first of 10 assessments TGA performed in 2018. All the inspections were routine, as opposed to being triggered by a specific concern, but the targets were selected on the grounds that they posed an above-average risk.
Inspectors identified four to six major findings during all 10 inspections. TGA categorizes a finding as major if it could affect the rights, safety or wellbeing of patients, or represents a violation of relevant laws and guidelines.
Of the 50 major findings, almost one-quarter related to the collection and collation of adverse drug reactions. Specific deficiencies included problems related to safety agreements between vendors and partners, and the reconciliation of adverse reaction reports with internal departments, vendors and partners. TGA identified failings with social media and patient support programs, too.
Mismanagement of reference safety information was another significant cause of major findings, in many cases due to delays in the updating of information. TGA censured companies for not keeping their reference safety information, package information and other resources up to date.
TGA found fault with the collection of adverse drug reactions and management of reference safety information in all 10 inspections, although some of the findings were classed as minor, indicating they were unlikely to pose a risk to patient safety.
Inspectors also found fault with the handling of adverse drug reactions and significant safety issues at nine of the 10 companies. Specific failures in these areas included the “non-conservative seriousness assessment of adverse reaction reports” and the failure to report significant safety issues within 72 hours. TGA classed 18 of the failures seen in these areas as major.
The rate of major findings is higher than that seen in the pharmacovigilance pilot program. In the test phase, TGA identified 25 major findings during 10 inspections of companies that volunteered to take part in the pilot. The doubling in the rate of major findings may reflect differences in the readiness of the 10 companies that volunteered and the 10 organizations targeted using the risk-based model.
TGA responded to the discovery of the deficiencies by telling the affected organizations to address the problems. The companies have either resolved or implemented corrective and preventive actions for all of the major findings identified in the inspections.
Hong Kong Proposes Overhaul of Guidance on Medical Device Responsible Persons
The Hong Kong Medical Device Control Office (MDCO) is preparing to overhaul its guidance on the listing of local responsible persons (LRPs) for new medical devices. MDCO is holding a series of events next month to brief the industry on the changes to the 2005 guidance.
LRPs are entities that place medical devices on the Hong Kong market and serve as a link between manufacturers, distributors, the public and the government. Under the current guidance, LRPs are also expected to maintain distribution records, handle complaints, share records with inspectors and perform a range of other tasks involved in the listing and oversight of medical devices.
The revised guidance maintains most of the tasks listed in the current text but also features some new additions. MDCO is proposing to require LRPs to implement and maintain documented procedures in the handling, storage and delivery of medical devices. That requirement, which is absent from the current guidance, is intended to ensure devices are protected from environmental factors that could affect their performance and stop nonconforming and recalled products from being sold.
Officials at MDCO have also expanded existing sections of the guidance, for example by providing more details of what is expected of LRP procedures for handling complaints. The revised guidance specifies that each LRP must have a 24-hour telephone number for receiving emergency complaints. MDCO provided additional information about complaint handling procedures, too.
Other changes include the addition of information about the removal of LRPs. If an LRP is permanently removed, MDCO will automatically de-list all the devices the person covered but continue to enforce post-market safety requirements. In the case of temporary LRP removals, MDCO may suspend the devices and prohibit the person from making new applications for product listings.
MDCO is set to discuss the guidance at a series of upcoming briefing sessions. The agency recently added a second event, on 8 April, in Cantonese after all the spaces on the first session were reserved. MDCO is accepting feedback on the draft until 18 April.
TGA Answers Questions on use of Evidence From Foreign Regulators in Device Filings
TGA has answered questions about the use of evidence from comparable overseas regulatory bodies in medical device applications. The text sets out what will happen in a variety of situations related to the use of market authorization evidence from foreign device agencies.
Australian officials, responding to the expert review of regulations, provided guidance on the use of reports from foreign agencies last year. The guidance detailed how TGA planned to make better use of the work of its international peers by permitting the use of resources including certificates from notified bodies in filings to bring devices to market in Australia.
The question and answer text builds on this advice by clarifying how TGA’s acceptance of overseas evidence impacts specific situations. For example, the document states what companies should do if their medical device single audit program covers non-in vitro diagnostic and IVD medical devices. In that situation, TGA expects companies to file two separate applications for manufacturer evidence, one for the IVDs and another for the non-IVD devices.
TGA Refuses to Issue GMP Clearances Unless Companies Contribute to Inspection Costs
TGA has clarified how it will handle organizations that decline to contribute to the cost of overseas good manufacturing practice (GMP) inspections. The agency will refuse to issue GMP clearances to companies that decline to pay the fee.
Officials clarified the situation in a minor update to the guide to Australian manufacturing licences and overseas GMP certification. Version 2.1 of the guide states companies will need a “reasonable justification” for not paying the inspection fee if they want to receive GMP clearance at the end of the inspection.
TGA also used the update to provide instructions for selecting site details and the name and activities of a manufacturer in the new licence application form.
has updated its application and submission user guide for listed and assessed listed medicines. The agency called version 4.0 of the document, the first revision since the introduction of assessed listed medicines, a “major rewrite.” Changes include the addition of a section on preparing to make applications. TGA Guide
has enacted revisions to its Medical Devices Rules
. The changes, which the government set out in a gazette notification, affect the manufacturing requirements for condoms and sterile surgical dressings. Indian officials proposed the changes last year and, having received no objections, are now going ahead with the legislative revisions. Gazette Notification