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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Regulatory News | 08 December 2015 | By Nick Paul Taylor
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 of medical device adverse event reports will have a checklist to work from, simplifying the process for them while also standardizing the data received by the center running the materiovigilance program. The form gives users space to communicate the details of the patient affected in the incident, where and when it took place, the cause, the seriousness of the event in terms of impact on human health and the current location of the device involved.
IPC also wants to gather the identifying details of the device. The form asks users to provide the Global Medical Device Nomenclature (GMDN) code and name of the device, plus information about the manufacturer and whether it is a reusable or single-use product. IPC is requesting the model, serial, batch and lot numbers, too. From a regulatory standpoint, the form contains space for details of the notified body in the country of manufacture and India.
The form is intended to facilitate materiovigilance data collection in India, while also helping to stop clusters of adverse events before they occur. Several sections of the form address near- and long-term prevention of adverse events. Immediate concerns are dealt with in sections requesting details of whether the device or any like it are still in use at the facility where the adverse event occurred. IPC also wants to know when the device was last maintained and calibrated.
IPC is accepting comments on the draft until 3 January. The consultation comes five months after the official launch of the Materiovigilance Programme of India (MvPI). As it stands, the reporting form is designed to be sent by post or email, despite the movement in Indian regulatory circles toward the online submission of information.
Chinese Politicians Push for Improvements to Generic Drug Quality
A group of influential Chinese politicians have called for regulators to take further actions to improve the quality of generic medicines sold in the country. Suggestions put forward by the conclave span from changes to the approval mechanism through to the ratcheting up of post-marketing oversight.
The ideas were put forward at the Chinese People's Political Consultative Conference (CPPCC), a gathering of representatives of multiple political parties and independent members. China Food and Drug Administration (CFDA) posted an overview of the discussion that took place at CPPCC, several facets of which could come to affect its day-to-day operation. Exactly what ideas will advance as far as coming into force is unclear, but CPPCC is set on the need for change if standards are to improve.
“Improving the quality of generic drugs concerns the sustainability of the health insurance system and matters to whether people can afford efficient drugs,” a statement from the CPPCC release, quoted by Xinhua and translated by Reuters, read. CPPCC attendees expressed an interest in overhauling the insurance and tendering processes to tilt the balance in favor of high-quality drugs, while others argued in favor of revisions to hospital management and methods.
Specific ideas put forward at CPPCC include the establishment of a set of standards hospitals can use to select drugs, plus the development of policies that encourage the procurement of high-quality medicines. The proposals shift the emphasis on how to encourage drug quality away from simply enforcing manufacturing standards and toward a more holistic model in which demand for substandard products is diminished.
Some of the suggestions put forward by CPPCC echo and reinforce initiatives already underway at CFDA. Attendees at the event advocated for changes to the approval process to cut the time it takes for generic medicines to come to market and eliminate the backlog of filings currently facing CFDA. The regulator is already working on projects with similar ambitions. Attendees also called for the promotion of upgrades to industry infrastructure and closer monitoring of drugs post-approval.
CFDA Post, Reuters
Singapore Revises Medical Device Change Notification System
The Health Sciences Agency (HSA) of Singapore has revised its guidance on the change notification system for medical devices. HSA used the update to tweak the list of actions that are applicable to change notification and clarify how different classes of medical device fit into the process.
In the latest update, which is the fourth revision of the document, HSA made more than 15 changes to its guidance. Among the more significant moves is a decision to switch the process for adding a different proprietary name to a device listing from the change notification process to the pre-market registration procedure. HSA also added a table to clarify which of the change notification processes — technical, review, administrative and notifications — apply to each class of medical device.
Another new section of the document deals with the handling of changes prompted by the discovery of adverse events or field safety corrective actions. Now, when reporting changes relating to adverse events, HSA wants filers to include documentation to support the amendment. Field Safety Notices, Dear ‘Healthcare Professional’ Letters, Health Hazard Evaluations and root cause analyses are all acceptable forms of supporting documentation.
HSA has also revised details of the process firms should follow when reporting and making adverse event-motivated changes to medical devices. When the change relates to an open reportable adverse event or ongoing field safety corrective action, the regulator is asking manufacturers of all classes of medical device to seek prior approval, unless they have written advice from HSA that states otherwise.
HSA Guidance, Emergo
TGA Posts Documents on Medical Device Submission Harmonization Pilot
The Therapeutic Goods Administration (TGA) of Australia has posted files relating to its participation in an International Medical Device Regulators Forum (IMDRF) harmonization project. Companies can use the documents to assess whether they want to participate in the pilot project.
IMDRF has set up the program to advance harmonization of submissions of premarket applications, specifically by creating an electronic file structure for in-vitro diagnostics (IVD) and other classes of medical device. The structure, known as the Table of Contents, is designed to cover the information needed by all of the regulators involved with the project, a list that includes CFDA and the United States Food and Drug Administration (FDA).
TGA participated in the development of the structures and has now published a page to facilitate the participation of the manufacturers it oversees in the pilot project. The list of documents provided by TGA includes the technical guide for the overall project, plus texts addressing the specifics of the program for IVDs and non-IVD medical devices. TGA has also shared a spreadsheet manufacturers can use to provide feedback on the pilot project.
HSA has warned consumers about a product branded “TCM Recipe Licozen Ointment.” Tests of the ointment have shown it to contain very high levels of arsenic, a toxic heavy metal that can lead to serious adverse events. The product was advertised online and sold in at least one store in central Singapore. At least one person applied to ointment to the skin of a young child. HSA Alert
Tags: India Pharmacopoeia, CFDA, CPPCC, China generic drugs, HSA, TGA