In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some stakeholders have told TGA that the code fails to adequately protect consumers from advertisements that cause “fear and distress.” The 2015 version of the code explicitly prohibited ads that contain language that could bring about fear or distress, but the current iteration lacks that provision.
Faced with the stakeholder feedback, TGA has proposed strengthening the code to ban ads that create fear or distress, for example because they cause a person to believe they are or could later suffer from a serious ailment. The agency wants to know if stakeholders support the explicit prohibition of ads that cause fear and distress and, if so, whether they approve of its proposed wording.
Elsewhere in the consultation paper, TGA addresses calls by stakeholders to streamline requirements for mandatory statements in advertisements. Stakeholders want TGA to streamline the requirements for a range of reasons, including the lack of space for mandatory statements in some ads, particularly on digital platforms.
TGA has proposed allowing advertisers to use a general statement, such as “THIS MEDICINE MAY NOT BE RIGHT FOR YOU,” and a link to the full health warnings associated with a product when they are “genuinely limited by physical space or character count.” The agency wants to learn if there is support for the change and when people consider it appropriate to allow the use of the shortened mandatory statement.
Work is also underway to change how the advertising code handles endorsements and testimonials. Stakeholders have made proposals including the banning of endorsements from former healthcare professionals “whose name and reputation may continue to carry significant weight” and lifting of the restrictions on testimonials from direct sellers. TGA has responded with three sets of potential changes that it has released for consultation.
TGA is accepting feedback on the proposals until 18 June.
TGA Notice, Consultation Paper
Philippine FDA starts consultation on postmarket surveillance requirements
The Philippine Food and Drug Administration (FDA) has begun a consultation about the postmarket surveillance of new drugs under monitored release. FDA wants to change its policies in response to new technologies and to harmonize its requirements with those of other countries.
Manufacturers of new drugs cleared for use under monitored release in the Philippines must fulfill postmarket research requirements for three years to gain a regular registration. The FDA policy dates back to 1987. Last year, FDA released guidance on the pharmacovigilance requirements for all drugs, leading it to re-evaluate its approach to the monitored release of new drugs.
The draft guidelines set out the postmarket surveillance requirements for new drugs classified as monitored release. Applicants need to submit a risk management plan that complies with the 2020 pharmacovigilance guidance and discusses plans to further characterize the safety concerns.
FDA will evaluate applications that are already pending but lack a local Phase IV study protocol using its new guidance. FDA will issue a postapproval letter if additional local pharmacovigilance activities are needed but the applicant met all the requirements.
The Philippine regulator is accepting feedback on the proposal until 24 May.
India establishes guidance on private imports of COVID-19 vaccines
India’s Central Drugs Standard Control Organization (CDSCO) has published guidance on how people and private sector organizations can import COVID-19 vaccines into the country. The guidance comes shortly after the India government permitted greater private sector involvement in vaccinations.
Starting 1 May, COVID-19 vaccine manufacturers can sell half of their doses to entities other than the national government. The change enabled Indian states and private hospitals to buy vaccines. Under the old system, private hospitals could only source vaccines from the Indian government and charge up to Rs 250 ($3.40) per dose for them. The government will now monitor what hospitals charge.
The guidance states organizations that want to import vaccines that are yet to be approved in India must get a license from CDSCO. Once a license is in place, the importer can bring the vaccine into the country and provide doses to the private sector. If the vaccine is already approved, any private sector entity can procure the vaccine from the licensee.
Pandemic pressures cause Malaysia’s NPRA to conduct 46% fewer GMP inspections
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) did 46% fewer good manufacturing practice (GMP) inspections last year as the pandemic constrained its ability to visit facilities.
NPRA performed remote inspections to enable it to continue monitoring compliance with GMPs and other regulatory requirements despite the disruption caused by COVID-19. Even so, the number of GMP inspections performed by NPRA fell to 208, down 46% versus 2019 and more than 50% on the average over the four previous years.
The regulator managed to maintain or increase its activity in other areas. NPRA performed slightly more good distribution practice inspections in 2020 than in the previous year and registered a record number of new products. Registrations of prescription products rose 48%.
Pakistan exempts medical devices from incoming rules until 2022
The Drug Regulatory Authority of Pakistan (DRAP) has given the medical device industry until next year to comply with incoming regulations.
When Pakistan issued the Medical Devices Rules, 2017, it exempted products from the requirements for nine to 24 months, depending on their risk classification. DRAP shared details of the time-limited exemptions in a document published more than 24 months ago, in January 2018.
Now, DRAP has revised the Medical Devices Rules, 2017. The update features a new timeline for the end of the exemptions. Class D medical devices are exempt until 31 March. Class A devices are exempt until 31 December 2022. The exemptions on all other devices end over the summer and fall of next year.
The exemptions come tied to certain requirements. For example, a notarized ISO 13485 and letter of authorization from the overseas manufacturer are needed to obtain clearance for a class A medical device from Pakistan Customs. A notarized free sale certificate and declaration of conformity are needed, too. Slightly different requirements apply to lower-risk medical devices.
Malaysia’s NPRA has updated its frequently asked questions (FAQ) document about AstraZeneca’s COVID-19 vaccine. The revised FAQ addresses the link between the vaccine and thromboembolic events, explaining that very rare cases of blood clots in combination with low levels of platelets have been reported and detailing when people should seek immediate medical attention. NPRA FAQ
The Philippine FDA has issued a public health warning about unregistered in-vitro diagnostics. The notice advises healthcare professionals and the general public not to buy or use certain tests for HIV, hepatitis B and blood types. None of the tests have undergone the FDA evaluation needed to ensure their quality and safety prior to use in the Philippines. FDA Notice
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