Asia Regulatory Roundup: Malaysia Posts Draft Medical Device Guidelines (7 July 2015)

Posted 07 July 2015 By Nick Paul Taylor

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Malaysia Posts Draft Medical Device Guidelines

Malaysia’s Medical Device Authority (MDA) has posted a pair of draft guidance documents detailing how companies should handle two aspects of post-marketing, namely complaint handling and field corrective actions (FCA).

The publication of the guidance documents comes three years after Malaysia issued new legislation covering the medical device industry and one year after MDA posted several policies designed to enable implementation of the laws. Publication of the guidance documents is a continuation of these efforts.

In the complaint handling draft, MDA calls on companies to inform it of all reports of death or serious injury linked to their devices. The brief guidance document also outlines how companies should record and maintain reports of serious adverse events, as well as the procedure for handling complaints.

In the draft covering FCAs, MDA details how manufacturers should fulfil their responsibilities to determine whether a FCA is needed, and the process they should follow once they have decided to take action. MDA has also included a field safety notice template firms can use to tell customers about a potential problem. Both drafts are open for comment until July 10.

In a separate development, MDA moved the deadline for registration of medical devices back by 12 months. The previous deadline was July 1, 2015.

Emergo, Complaint Handling Draft, FCA Draft, MDA Exemption

India Plans Jail Terms for Violators of Clinical Trial Protocols

The Indian government is planning to strengthen the punishments for anyone found to have violated clinical trial rules, notably by introducing one-year prison sentences for missteps that harm a patient, The Economic Times reports.

Officials began working on the changes to encourage clinical trial sponsors to comply with guidelines from the health ministry, which were drafted in response to directives from the Supreme Court. As it stands, companies must pay compensation when a patient is harmed in a clinical trial but the government wants to see stronger deterrents put in place. As well as adding a one-year jail term, the proposed law would give the Drugs Controller General of India (DCGI) final say on the punishment.

The DCGI is expected to consider the opinion of an independent expert committee before making a ruling but ultimately is the sole decision maker. Giving DCGI this power is intended to remove anyone involved with the running of the clinical trial from the decision making process, thus lessening the risk of conflicts of interest affecting the outcome. “In the current system often there is a conflict of interest,” an anonymous official source said.

Officials also want to establish the power to hand out punishments even in cases when nobody is harmed by a clinical trial violation. In such cases, the proposal mandates the payment of a fine of up to Rs 3 lakh ($4,700). The proposed changes are expected to be sent to parliament in the upcoming monsoon session that will run from July 21 to August 13.

The Economic Times

NPPA Dismisses Device Manufacturers’ Claims of Exemption from Price Monitoring

India’s National Pharmaceutical Pricing Authority (NPPA) has reiterated its request for pricing data from manufacturers of orthopedic implants. The follow-up letter was sent in response to attempts by some manufacturers to claim exemption from pricing legislation.

NPPA was quick to dismiss the claims, telling manufacturers that the classification of orthopedic implants as drugs under the Drugs and Cosmetics Act of 1940 means such products fall within the remit of the Drug Prices Control Order (DPCO) of 2013. Having restated its authority, NPPA went on to demand companies share details of the prices for which certain orthopedic implants were sold over the past three years, the Press Trust of India reports.

The companies have one week to respond. NPPA is using the powers conferred to it by DPCO to monitor the sales of 14 classes of medical devices to gather data on the price of orthopedic implants as they move along the supply chain. Companies must give NPPA data on the factory price, distributor cost and maximum retail price (MRP), as well as the rise in MRP over the past three years.

Press Trust of India

Australia Moves Clinical Trial Application Process Online

Australia’s Therapeutic Goods Administration (TGA) has become the latest regulator to move part of its operation online. As of July 1, anyone wishing to submit a clinical trial notification (CTN) to TGA must use its new online form.

TGA is dropping support for the paper forms immediately as they contain different information than the online submissions, although companies can choose to submit via both mediums. The regulator is also promising to work with any sponsors affected by the changes, which it framed as part of its push to streamline the clinical trial application process.

By moving online, TGA is aiming to end the need for sponsors to submit original signatures from the principal investigator, approval authority and ethics committee, while also cutting their administrative burdens. The online system will allow applicants to track their notifications, make updates to their information and manage invoice generation and payment.   

TGA Notice

Other News:

The Indian health ministry and Central Drugs Standard Control Organization (CDSCO) have started studying regulations in other countries in order to create a global benchmark for quality and good manufacturing practices. Regulations from Japan, Europe and emerging markets are part of the review. PharmaBiz

China Food and Drug Administration (CFDA) has released a drug quality management specification document. The document is intended to strengthen the regulation and practice of pharmaceutical quality management in China, a goal it sets out to achieve by listing requirements with which firms must comply. Procurement, storage and distribution are covered by the text. CFDA Notice (Chinese)

Complaints by villagers in India have put Biocon at the center of an investigation into waste disposal. The villagers complained after stopping four trucks carrying waste from Biocon. The company admits the waste came from its facility but reassured villagers it is a nontoxic, biodegradable mix of inert cell mass. The waste has a pungent smell, though. The Hindu, Indian Express

Pakistan’s commerce ministry is working on a trade policy to increase drug exports. The plan is to offer tax breaks, support with equipment purchases and help with investments in compliance. A Pharmaceutical & Cosmetics Export Promotion Council will also be created. The measures are intended to stimulate growth in exports between now and 2018. Business Recorder

The Indian Pharmacopoeia Commission (IPC) has released guidance on the development of monographs for herbal products. IPC wrote the document to help manufacturers understand how to develop monographs that are fit for inclusion in the Indian Pharmacopoeia. In doing so, IPC hopes to ensure the quality of herbs used in medicines, foods and cosmetics. PharmaBiz

China is claiming that online sales of medicines topped $1 trillion last year. The claim is based on an analysis of sales at 300 government-recognized outlets by a state organization. Donkey-hide gelatin products to treat bleeding, erectile dysfunction drugs and hair loss remedies topped the sales chart, which covered just over-the-counter medicines and dietary supplements. China Daily

The World Health Organization (WHO) has selected 40 ADR Monitoring Centres (AMCs) in India to link to its database. Once connected, the 40 AMCs will use VigiFlow software to report adverse events to WHO’s coordinating center in Sweden, giving the public health organization are fuller picture of the safety of medicines around the world. PharmaBiz

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