Asia-Pacific roundup: Malaysian Device Authority releases Code of Ethics and Conduct

Gatherings

| August 09, 2022 | By Nick Paul Taylor

Malaysia’s Medical Device Authority (MDA) has published a Code of Ethics and Conduct which outlines its approach to matters such as conflict of interest, confidentiality and receipt of gifts.

The document is intended to guide the behavior of MDA employees, including full-time and part-time employees and contractors, while reinforcing their integrity. To achieve these goals, the agency has provided a set of definitions of terms, including ownership and bribery, and defined their relationship to the rules that govern the behavior of its employees.

A section of the guide describes the conflict of interest legislation that applies to MDA employees. The guide explains that a 2000 law prohibits agents from behaving in a way that puts their personal interests in conflict with their duties to MDA. The guide also covers a 2009 anti-corruption law that defines “parents” and “associates”. MDA employees must declare their interests orally and in writing and recuse themselves from decision-making if there is a conflict of interest with their official duties.

Another section of the document presents the code of conduct. The code covers a wide range of topics such as clothing employees may wear, rules on outside employment, prohibition on using MDA assets for personal gain, and the need to maintain the confidentiality of classified documents. . Employees should not be in substantial financial debt, as defined in the guide, receive or give gifts or wear the symbol of a political party in the performance of their duties.

MDA Code (Malaysian)

TGA Begins Comirnaty Evaluation of Pfizer in Children Ages 6 Months and Older

Australia’s Therapeutic Goods Administration (TGA) has begun its evaluation of Pfizer and BioNTech’s Comirnaty COVID-19 vaccine in children aged six months to five years.

The TGA tentatively approved Moderna’s rival mRNA vaccine, Spikevax, for use in children aged six months to six years last month. However, the use of Comirnaty remains limited to children aged five and over. TGA approved a lower dose of 10 micrograms of Comirnaty for use in children aged five to 11 late last year.

The filing of an application to reduce the minimum age to six months proposes a further lowering of the dose. Pfizer is seeking tentative approval for a 3 microgram dose in young children. While older children and adults receive two doses at least three weeks apart, TGA is evaluating a three-dose treatment in the younger age group.

Pfizer selected the diet based on the results of a Phase 2/3 randomized clinical trial involving 4,526 children aged six months to five years. In the study, participants received a third dose of 3 micrograms at least two months after their second dose. The clinical trial found that the diet elicited a strong immune response, leading to emergency use authorization in the United States and filings in other regions.

TGA Reviews

Australia seeks experts to serve on advisory boards

The TGA has launched a call for applications from experts wishing to join its advisory boards on topics including biologics, drugs, vaccines and medical devices.

Advisory committees provide independent expert advice on specific technical issues relating to the regulation of medicines, medical devices, vaccines and other products and substances. TGA gathers the views of advisory committee members throughout the life cycle of the therapeutic product, from pre-market evaluation to post-market product safety.

TGA is hosting a webinar to provide information to potential applicants on August 24. Interested parties have until late September 4 to submit applications along with a cover letter and up-to-date resume. It is planned to appoint new members by December with a view to their entry into force in January 2023.

TGA Reviews, More

TGA launches consultation on determining permitted ingredients

TGA invites comments on proposals related to the need for professional health care oversight for ingredients Chelidonium majus and Larrea tridentata and the risk of liver damage associated with Valeriana officianalis.

All three ingredients are included in the Therapeutic Goods (Permitted Ingredients) Determination, a legislative instrument that specifies the substances that can be used in scheduled drugs and the rules for their use. TGA is proposing the changes as part of its ongoing review of legislation to ensure the safe use of ingredients in low-risk medicines.

Currently, products containing Chelidonium majus and Larrea tridentata should carry a warning label stating that they should only be used under the supervision of a healthcare professional. TGA believes that having consumers seek healthcare oversight “is incongruous with the low-risk framework for listed drugs,” leading it to propose dropping the statement in favor of a warning according to which users should stop taking the product and consult their doctor if they experience symptoms such as yellowing of the skin and dark urine.

The other proposed changes follow a report of serious drug-induced liver injury in a consumer who took valerian. Although such adverse events are rare, the seriousness led TGA to propose adding a warning that valerian can harm the liver and advising people to stop taking the product and consult their doctor if they develop certain symptoms.

TGA is accepting comments until September 15.

TGA Reviews

India’s NPPA again extends price controls on medical devices used in response to COVID

India’s National Pharmaceutical Pricing Authority (NPPA) has proposed extending price controls on certain medical devices from July 31 to December 31.

Price controls apply to pulse oximeters, blood pressure monitors, nebulizers, digital thermometers and glucometers. The NPPA set the maximum retail price for products last year to control their prices during the COVID-19 pandemic. The action sent prices down by up to 69% and hit companies such as Abbott and Roche.

Now, NPPA has decided to maintain the price caps until at least the end of the year. The NPPA originally planned to lift the 70% cap on trading margins late last year, but extended the requirements, first until the end of July and now until the end of 2022.

NPPA Notice

MDA identifies 10,000 unregistered dressing units after receiving tip

Malaysia’s MDA has found 10,000 unregistered dressing units after reports of import activity led it to inspect a warehouse at a port on the outskirts of Johor city.

The report of unregistered medical device import activities on the site led to the confiscation of the dressing units under a breach of the Medical Devices Authority Act 2012. Possible penalties under the law include prison terms of up to three years and fines of up to RM 200,000 ($45,000).

MDA used the regulatory action to remind organizations wishing to import medical devices of the need to obtain a valid establishment license under the 2012 law. The agency also advised the public to check whether a medical device has a valid registration before purchasing a product.

MDA Notice (Malay)

Other news:

The Drug Controller General of India (DCGI) has published a list of classifications for rehabilitation medical devices. The list assigns 60 devices such as prosthetic limbs, crutches and back braces to risk categories. All medical devices belong to class A, B or C. Notice DCGI

© 2022 Society of Regulatory Affairs Professionals.

Comments are closed.