Asia-Pacific Roundup: India lowers bar for approval of COVID-19 vaccines already authorized overseas

RoundupsRoundups | 08 June 2021 |  By 

India’s Central Drugs Standard Control Organization (CDSCO) has relaxed the requirements for the restricted-use emergency authorization of COVID-19 vaccines that are already on the market in some overseas territories.
The change exempts developers of certain COVID-19 vaccines from the need to run post-approval bridging clinical trials and for every batch to undergo testing at the Central Drugs Laboratory at a site in Kasauli. CDSCO is granting the exemption to vaccines that are already approved for emergency use in the US, EU, UK or Japan, or are part of the World Health Organization’s emergency use listing and have been given to millions of people in those territories.
CDSCO relaxed the requirements for products cleared for use by those authorities because of the “huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines to meet the national requirements.”
India granted restricted-use approval to the AstraZeneca-Serum Institute of India COVID-19 vaccine Covishield and Bharat Biotech’s Covaxin early in the year, before adding Russia’s Sputnik V to the list of cleared prophylactics in April. However, India’s COVID-19 Subject Expert Committee recommended against approving Pfizer and BioNTech’s vaccine over reports of recipients developing palsy and a lack of local data.
Pfizer withdrew its application in response to the recommendation, depriving India of a vaccine that has played a critical role in the COVID-19 vaccination campaigns of many other countries. Moderna and Johnson & Johnson are also yet to get clearance to sell their vaccines in India. The rule change could see more foreign manufacturers introduce COVID-19 vaccines in India, although they will still face some additional requirements.
The testing exemption only applies if the batch or lot of vaccine has been certified and released by a national control laboratory in the country of origin. Even then, the laboratory at Kasauli will review the summary lot protocol and certificate of analysis as per the standard procedures. CDSCO is also requiring the safety outcomes of the first 100 recipients of a vaccine to be monitored for seven days before the prophylactic is included in the wider immunization program. 
CDSCO Notice
TGA relaxes rules to allow COVID-19 vaccination communication and incentives
Australia’s Therapeutic Goods Administration (TGA) has temporarily relaxed the rules on COVID-19 vaccines to allow healthcare professionals and businesses to talk more freely about the products and offer rewards for people who are fully vaccinated.
Until the end of next year, TGA will allow healthcare professionals to publicly support vaccination, counter misinformation and share logistical information about when and where people can receive COVID-19 vaccines. The new rules also permit businesses to offer rewards such as store vouchers, discounts or frequent flyer points to people who are fully vaccinated, as well as to make their own materials to support COVID-19 vaccination.
The more flexible regulatory arrangements come with some stipulations. Businesses can choose to limit rewards to their own employees or members of a scheme but cannot restrict them to people who got their vaccines after the announcement of the incentive.
There are also limits on what information can be conveyed in materials to support the vaccination campaign. References to specific brands, comparisons of the vaccines, the promotion of unapproved products and any false or misleading statements are prohibited. The content must be consistent with current government messaging about the COVID-19 vaccination program. 
Australia revised its policies amid concerns that vaccine hesitancy will stop the country from reaching herd immunity. One set of surveys found the proportion of people who would get vaccinated as soon as possible fell from 56% to 42% between October and late April. The proportion of people who said they would never get vaccinated doubled, rising from 8% to 16%.
TGA Notice, TGA Guidance
TGA seeks feedback on ways to improve personalized medical device regulations
TGA is seeking feedback on ways to improve its framework for the regulation of personalized medical devices in light of negative feedback. Stakeholders have criticized the policy for duplicating existing rules, creating requirements that are disproportionate to risk and imposing unreasonable burdens.
The regulatory changes commenced in February, but a transition period means eligible sponsors and manufacturers will only feel the full impact in November 2024. Given the criticism, TGA is using the transition period to consider excluding products such as spectacle frames from the regulation and exempting some Class I patient-matched medical devices from inclusion in the Australian Register of Therapeutic Goods (ARTG).
TGA is unwilling to exclude higher-risk patient-matched medical devices from the ARTG but has put forward a different approach to Class IIa products. The agency is proposing an alternative conformity assessment procedure that frees the manufacturer from the need to have a quality management system that has been certified by TGA or another third-party conformity assessment body.
Stakeholders have a chance to say whether they agree with the proposed exclusions, exemptions and alternative procedures, and if they want to see further tweaks to the plans. TGA is accepting feedback until 5 July.
TGA Notice, Consultation Document
Australia to start accepting conformity assessment body applications next month
Applications to become an Australian Conformity Assessment Body (AU CAB) will open on 1 July. The acceptance of applications will mark the start of efforts to create a pool of organizations that issue conformity assessment certificates for medical devices under Australian law.
Currently, Australian medical device manufacturers need to apply to TGA or a foreign notified body for conformity assessment certificates. TGA has 255 days to complete assessments. The Australian government agreed to allow other organizations to perform conformity assessments to increase the flexibility and timeliness of the process.
TGA is set to publish information on how to apply and guidance on the types of devices AU CABs can assess. So far, TGA has said, “The determination of an AU CAB requires demonstrated competency and recognition for undertaking medical device conformity assessments and quality management system auditing.”
The agency expects AU CABs will be Australian-based corporations that use the same systems and controls as their parent and affiliated organizations that have already been assessed by comparable overseas regulators. TGA cited a notified body designated under the European Union Medical Devices Regulation as an example of a potential parent or affiliated organization.
TGA Notice
India shares guidelines on scheme to incentivize local manufacturing investment
India’s Department of Pharmaceuticals has published operational guidelines for a scheme designed to incentivize investment in local manufacturing and the production of high-value goods.
The production-linked incentive scheme for pharmaceuticals will provide Rs 150 billion ($2 billion) to support manufacturing of formulations, biopharmaceuticals, active pharmaceutical ingredients, key starting materials and other products in the drug and in vitro diagnostic supply chains.
India will select up to 55 applicants across three groups defined by global manufacturing revenues in the 2019 to 2020 fiscal year. The department said the “gestation period” for the plan will be the 2021 to 2022 year, given “the time taken for selection of participants, establishment of manufacturing facility, complexity of the manufacturing process involved and requirement of regulatory approvals.”
Operational Guidelines
Other News:
India has capped the price of oxygen concentrators after COVID-19 caused a surge in demand. NPPA Notice


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