Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India to Treat Implants and Imaging Equipment as Drugs From April 2020
India is pushing ahead with previously discussed plans to categorize certain classes of medical device as drugs. The change will mean implants and imaging equipment are subject to more burdensome regulatory requirements than in the past.
The Drugs Technical Advisory Board (DTAB) floated the idea of reclassifying “high end equipment” last year, leading the Drug Controller General of India (DCGI) Dr. Eswara Reddy to seek the industry’s feedback on the idea. Seven months later, India has committed to reclassifying the devices in April 2020.
The list of devices affected by the reclassification is unchanged from that released by DCGI in June, and only slightly different from the original DTAB proposal. That means the following devices will be regulated under drug rules:
- All implantable medical devices
- CT scan equipment
- MRI equipment
- Dialysis machines
- PET equipment
- X-ray machines
- Bone marrow cell separator
The reclassification is a major change for the affected devices. India lacks mechanisms to regulate the quality and efficacy of most medical devices. Of the thousands of types of devices sold in the country, just the 23 already treated as drugs are under the oversight of the Central Drugs Standard Control Organization (CDSCO). Following the reclassification, CDSCO will oversee approvals to import, make and sell the eight additional device categories.
Pressure to increase oversight of medical devices in India has intensified as the controversy over the effects of Johnson & Johnson’s hip implants has raised awareness about how the system works today. Once the reclassification takes place, devices similar to the J&J hip implants at the center of the safety concerns will be subject to more stringent regulations in India.
TGA Clarifies Guidance on Recently Adopted Quarantine Mechanism
TGA has clarified its guidance on the quarantine mechanism it introduced during its latest revision of the recall procedure in Australia. The update significantly expands TGA’s advice on the use of the mechanism to suspend the supply of a product pending further investigation.
When TGA released its guidance on the Uniform Recall Procedure for Therapeutic Goods (URPTG) late in 2017, it provided scant advice on the quarantine mechanism, despite it being a new addition to the range of non-recall actions available to manufacturers. The guidance featured a few sentences that did little more than define the mechanism.
Version 2.1 of the URPTG goes into far more detail. The updated guidance states that manufacturers should consider quarantining goods when they identify a defect that may affect the safety, efficacy or performance of a drug or device. When a company decides to take this action, it must send the final signed quarantine notice for TGA to review.
TGA will send the notice to state recall coordinators, professional bodies and other organizations. The manufacturer is responsible for distributing the notice to either the wholesale, hospital or retail level, depending on the depth of the supply of the goods.
Once the investigation into the defect that triggered the supply suspension is complete, TGA will review the findings before deciding whether to lift the quarantine or initiate a further recall action.
The quarantine section is one of two parts of the URPTG to undergo a significant overhaul in the latest update. The other major change covers consumer-level recalls. TGA wants to adopt “a more flexible approach” to consumer recall notices, having previously made companies take out an advertisement in print and electronic daily newspapers in each state in which a recalled product was distributed.
That requirement is absent from the latest version of the guidance. Instead, TGA is telling companies to distribute recall notices “through a variety of means as appropriate” and with “regard to the global multimedia environment.” Daily print newspapers top the list of venues TGA wants companies to consider when informing the public of a recall, but the prescriptive approach is gone. In making the changes, TGA has started to refer to the communications as notices, not advertisements.
To support the new, more manufacturer-led approach, TGA is advising companies to create strategies for reaching consumers. The goal is for manufacturers to know who their customers are and how these people access their products. Armed with this information, TGA thinks manufacturers can target their recall notices at their customers, potentially eliminating the need for blanket, mass-market advertisements.
TGA Creates Guidance to Help Manufacturers Interpret PIC/S Guide to GMP
TGA has released a clutch of guidance documents intended to help manufacturers interpret the PIC/S Guide to GMP. The documents cover the production of sterile radiopharmaceuticals labeled with fluorine-18, release for supply (RFS) and releasing medicines manufactured at multiple sites.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practices (GMPs) is an instrument for harmonization of production practices around the world. However, aspects of the guide can be interpreted in different ways, creating a need for national regulators to help companies understand their takes on the document.
TGA released three technical guidance documents this week to provide such clarification. In each case, TGA has updated an existing technical document in light of revision 13 of the PIC/S guide. TGA adopted the guide at the start of 2018 but told its inspectors to take a “pragmatic” approach to the enforcement of new requirements throughout last year.
, Multi-site Guidance
, Radiopharmaceutical Guidance