Asia-Pacific Roundup: Malaysian device authority posts code of ethics and conduct

RoundupsRoundups | 09 August 2022 | By

Malaysia’s Medical Device Authority (MDA) has released a code of ethics and conduct that describes its approach to subjects such as conflicts of interest, confidentiality and the receipt of gifts.
 
The document is intended to guide the behavior of MDA employees, including full and part-time staffers and contractors, while strengthening their integrity. To achieve those goals, the agency has provided a set of definitions of terms including property and bribery and set out how they relate to the rules that govern the behavior of its employees.
 
One section of the guide describes the conflict-of-interest legislation that applies to MDA employees. The guide explains that a 2000 law bans officers from behaving in ways that cause their personal interests to conflict with their duties to MDA. The guide also covers an anti-corruption law from 2009 that defines “relatives” and “associates.” MDA employees must declare their interests orally and in writing and withdraw from making decisions when there is a conflict of interest with their official duties.
 
Another section of the document sets out the code of conduct. The code spans a broad range of topics such as the clothes employees can wear, the rules on external employment, the ban on using MDA assets for personal gain and the need to retain the confidentiality of classified documents. Employees should not be in serious financial debt, a term defined in the guide, receive or give gifts, or wear the symbol of a political party while carrying out their duties.
 
MDA Code (Malaysian)
 
TGA starts evaluation of Pfizer’s Comirnaty in kids aged 6 months and up
 
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.
 
TGA provisionally approved Moderna’s rival mRNA vaccine Spikevax for use in children aged six months to six years last month. However, use of Comirnaty remains limited to children aged five years and up. TGA approved a lower, 10 microgram dose of Comirnaty for use in children aged five to 11 years late last year.
 
The filing to bring the minimum age down to six months proposes a further lowering of the dose. Pfizer is seeking provisional approval of a 3-microgram dose in younger children. Whereas older children and adults receive two doses at least three weeks apart, TGA is evaluating a three-dose course in the younger age group.
 
Pfizer selected the regimen considering the results of a Phase 2/3 randomized clinical trial of 4,526 children aged six months to five years. In the study, participants received a third 3 microgram dose at least two months after their second dose. The clinical trial found the regimen elicited a strong immune response, leading to emergency use authorization in the US and filings in other regions.
 
TGA Notice
 
Australia seeks experts to serve on advisory committees
 
TGA has put out a call for applications from experts who want to join its advisory committees on topics such as biologicals, medicines, vaccines and medical devices.
 
The advisory committees provide independent expert advice on specific technical matters relating to the regulation of medicines, medical devices, vaccines and other products and substances. TGA gathers the views of advisory committee members throughout the therapeutic product life cycle, from pre-market evaluation to post-market product safety.
 
TGA is holding a webinar to provide information to potential applicants on 24 August. Interested parties have until late on 4 September to submit applications that include a cover letter and current curriculum vitae. The plan is to appoint new members by December with a view to them starting in January 2023.
 
TGA Notice, More
 
TGA kicks off consultation on permissible ingredients determination
 
TGA is seeking feedback on proposals related to the need for healthcare professional supervision for the ingredients Chelidonium majus and Larrea tridentata and the risk of liver injury associated with Valeriana officianalis.
 
The three ingredients are included in the Therapeutic Goods (Permissible Ingredients) Determination, a legislative instrument that specifies the substances available for use in listed medicines and the rules on their use. TGA is proposing the changes as part of its ongoing review of the legislation to ensure the safe use of the ingredients in low-risk medicines.
 
Currently, products containing Chelidonium majus and Larrea tridentata must carry a warning label that states they should only be used under the supervision of a healthcare professional. TGA thinks making consumers seek healthcare oversight “is incongruous with the low-risk framework for listed medicines,” leading it to propose dropping the statement in favor of a warning that users should stop taking the product and see their doctor if they have symptoms such as the 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. While such adverse events are rare, the severity led TGA to propose adding a warning that valerian may harm the liver and advising people to stop taking the product and see their doctor if they develop certain symptoms.
 
TGA is accepting feedback until 15 September.
 
TGA Notice
 
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 the price controls on certain medical devices from 31 July to 31 December.
 
The price controls apply to pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers and glucometers. NPPA fixed the maximum retail price of the products last year to control their prices during the COVID-19 pandemic. The action lowered the prices by as much as 69% and hit companies including Abbott and Roche.
 
Now, NPPA has decided to retain the price caps until at least the end of the year. NPPA originally planned to lift the 70% cap on trade margins at the end of 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 wound dressing units after receiving tip
 
Malaysia’s MDA has found 10,000 unregistered wound dressing units after information about import activities led it to inspect a warehouse at a port on the outskirts of the city of Johor.
 
The report of unregistered medical device import activities at the location led to the confiscation of the wound dressing units under a violation of the Medical Device Authority Act 2012. Possible penalties under the law include prison sentences of up to three years and fines of up to RM 200,000 ($45,000).
 
MDA used the regulatory action to remind organizations that want to import medical devices of the need to obtain a valid establishment license under the 2012 act. The agency also advised the public to check if a medical device has a valid registration before buying 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 of the medical devices fall into Class A, B or C. DCGI Notice

 

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