Asia-Pacific Roundup: India relaxes rules on COVID treatments
The Indian government is deferring some routine requirements for developing and manufacturing to help get COVID-19 therapeutics to market.“Provided that the requirement of prior permission from the Central Licensing Authority under rule 81 of the New Drugs and Clinical Trials Rules, 2019 to manufacture the new drug as required under rule 83 of the said rules shall be deferred in public interest to meet the emergent situation arisen out of COVID-19,” the notification states.
Rule 81 covers granting permission to manufacture a new drug for sale or distribution. Rule 83 explains that “the person intending to manufacture a new drug for sale shall make an application for grant of license to manufacture for sale or for distribution.”
The notification goes on to state that organizations that take advantage of the deferral of the normal requirements “shall obtain the said permission after successful completion of the clinical trial and submission of application along with fees, data and particulars in accordance with the provisions of the New Drugs and Clinical Trials Rules, 2019.”
The COVID-19 provisions take precedence over existing law, reflecting the public interest.
Gazette Notification
Malaysia seeks feedback on draft rules for classifying medical devices
Malaysia’s Medical Device Authority (MDA) is holding a consultation on proposed rules of classification for general medical devices and products used in rehabilitation, physiotherapy and speech therapy.
In the general medical device guidance, MDA sets out principles for classifying products, explaining that it will assess risk based on factors such as the intended purpose of the technology, including how long the device is in contact with the body, whether it has a biological effect on the body, and whether it is used for diagnosis or treatment.
MDA has provided decision trees for different types of devices, such as invasive and non-invasive, to help manufacturers understand how their products may be regulated. For example, a non-invasive device that modifies the biological or chemical composition of liquids such as blood intended for infusion will be in Class C, unless the action is filtration, centrifugation, or exchange of gas or heat.
Rehabilitation, physiotherapy and speech therapy devices primarily consists of a list of product types such as training stairs and balance boards. For each item, MDA has stated whether the product is classed as a medical device or not. MDA is proposing to treat training stairs, but not balance boards, as medical devices.
MDA is accepting feedback on the general and rehabilitation guidelines until 28 February and 2 March, respectively.
Draft Guidance, More
Pakistan posts draft guidelines on reporting adverse events by patients
The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on draft guidelines about the reporting of adverse events by patients and their relatives, in an effort to increase participation in the country’s adverse event reporting system.
There is a “dire need” for a “vibrant national pharmacovigilance center to monitor the safety of therapeutic goods” after they come to market, according to DRAP. The agency, working through the National Pharmacovigilance Centre, has developed web-based and mobile forms to encourage reporting but also needs to seeks a culture in which patients spontaneously submit events.
The guidance explains why patients should report adverse events, what they should report, and when and how they can submit the information. Patients can file reports through the pharmaceutical company, the guidance states, but also have multiple online and phone-based options for self-reporting, as well as the chance to file in collaboration with their healthcare professional. DRAP is asking patients to only report each adverse event via one channel.
The heart of the guidance explains the steps patients need to follow to report adverse events themselves, either through the Med Vigilance E Reporting System, the Med Safety Mobile Application or landlines. Elsewhere, DRAP explains the information patients need to report, such as a description of the adverse event and details of the therapeutic goods involved.
Draft Guidelines
Indian oncology committee backs Novartis clinical trial waiver requests
India’s oncology Subject Expert Committee (SEC) has granted clinical trial waiver requests from pharma companies including Novartis. The committee recommended granting Novartis permission to import and market the cancer drugs dabrafenib and trametinib.
Dabrafenib and trametinib, sold respectively as Tafinlar and Mekinist, are targeted drugs that can be used in combination to treat melanoma and non-small cell lung cancer. Novartis submitted a request to import and market the drugs for use in combination in the treatment of certain melanomas and thyroid cancers. As part of the request, Novartis sought a clinical trial waiver to free it from the need to run local studies.
SEC accepted the proposal at a meeting that also saw it consider requests by Baxalta Bioscience India, now part of Takeda, and Allergan, now part of AbbVie. Baxalta requested a clinical trial waiver and right to market for ixazomib and brigatinib, which are sold respectively as Ninlaro and Alunbrig. The Allergan request covered venetoclax, also known as Venclexta.
The oncology committee recommended granting permission to import all three drugs, while requesting that Baxalta and Allergan run Phase 4 clinical trials and submit protocols within two months of winning approval.
Meeting Minutes
AstraZeneca wins provisional approval of COVID booster shot in Australia
Australia’s Therapeutic Goods Administration (TGA) has provisionally approved AstraZeneca’s COVID-19 vaccine for use as a booster shot, although it is unclear how widely the product will be used.
Moderna’s Spikevax and Pfizer’s Comirnaty, both of which use mRNA to induce immunity against SARS-CoV-2, are the preferred booster vaccines in Australia, irrespective of which product an individual received for their primary course. However, AstraZeneca’s Vaxzevria may now be used as a booster in some contexts.
TGA said the booster “may be given if clinically indicated with reference to official guidance regarding the use of a heterologous third dose (e.g. mRNA vaccine),” meaning that “the decision to receive Vaxzevria as a booster must be made in consultation with a medical professional.”
TGA Notice
Other news:
TGA has published a substitution instrument to address a shortage of Bristol Myers Squibb’s Orencia. The company has told TGA about shortages of multiple versions of the medicine because of manufacturing delays. Faced with shortages of the arthritis drug, TGA has cleared pharmacists to dispense the single dose syringe and autoinjector versions of Orencia interchangeably. TGA Notice
