Reduce application review time, increase access to new drugs and vaccines

According to Deputy Minister of Health Do Xuan Tuyen, the Ministry of Health is reviewing and amending the Pharmacy Law to submit to the National Assembly for consideration with the orientation of attracting investment in research and development of technology, production or technology transfer to produce pharmaceutical substances, new drugs, original branded drugs, rare drugs, first generic drugs, high-tech drugs, vaccines and biological products from foreign pharmaceutical corporations in Vietnam, proactively developing sustainable domestic production while promoting pharmaceutical exports to advanced markets.

The Ministry of Health proposes policies to attract investment and develop new and rare drugs.

Providing specific information on important proposals affecting investment attraction, pharmaceutical production and trading as well as opportunities to access new drugs, the representative of the Drug Administration Department said that regarding administrative procedures, the draft Law on Pharmacy has the following proposals: simplifying the dossier for extending, changing, and supplementing the registration certificate for circulation of drugs and pharmaceutical ingredients; regulating cases of extending, changing, and supplementing the registration certificate for circulation without having to go through the Advisory Council for granting the registration certificate for circulation of drugs or without having to wait for the approval of the Ministry of Health to simplify administrative procedures.

The draft also proposes to reduce the time for processing change dossiers, which stipulates that only 3 months of announcement is required to be made down to 15 working days; the time limit for granting a circulation registration certificate is reduced from 12 months to 9 months in case of recognition and reference; and no more than 10 working days for circulation registration dossiers of new drugs with indications for use in prevention and treatment of group A diseases that have been declared epidemics and have been licensed for circulation or licensed for use in emergency cases or licensed for circulation and use with conditions by one of the strict drug management agencies announced by the World Health Organization.

The above proposals aim to speed up the licensing process, ensuring people's early access to drugs.

Pharmaceutical security, complex epidemic response

After the Covid-19 pandemic, countries have realized that vaccines play an important role in disease prevention. Director of the Department of Science, Technology and Training of the Ministry of Health Nguyen Ngo Quang said that domestic pharmaceutical companies are providing 11/12 vaccines for expanded immunization. Human resources and equipment conditions allow the country to receive and transfer production of new vaccines in the future.

Cutting down on licensing procedures while still ensuring safety and effectiveness helps increase access to new drugs and vaccines.

According to the Department of Science, Technology and Training, along with encouraging the development of vaccine technology, procedures for clinical research and licensing of new vaccines are being carried out with streamlined procedures but still ensuring the first principle, which is: safety and effectiveness for users.

Representatives of several pharmaceutical corporations said that the draft Pharmaceutical Law is currently receiving attention, because the policy is the basis for corporations to have strategies for investment, transfer and product development in Vietnam.

With advantages in pharmaceuticals for treating cancer, rare diseases and vaccines, the General Director of Southeast Asia and India of Takeda Company (Japan) affirmed that they always value the value of partnerships in building a sustainable healthcare system; improving access to safe and effective prevention and treatment methods for patients, including vaccines.

Regarding the important milestone in disease prevention when the Ministry of Health approved Takeda's dengue vaccine last May, in the context of increasing dengue fever in Vietnam, Takeda representative affirmed: "We will continue to cooperate with health agencies, universities, research institutes, partners and public and service vaccination centers, and provide training programs for health workers on safe vaccination practices."

Do not interrupt the drug supply

Regarding the proposals in the draft Pharmaceutical Law, the representative of Pharma group in Vietnam said that he fully supports the new positive points, especially the policies: speeding up access to new drugs, vaccines and biological products; simplifying registration renewal procedures to remove the current administrative burden, avoiding the risk of drug shortages as has happened in the past; special preferential policies to develop the pharmaceutical industry, such as offering incentives for processing activities, technology transfer of new drugs, invented drugs as well as research and development activities.

At the same time, Pharma group representatives also expect the pharmaceutical law to be passed by the National Assembly in 2024; the implementation process will be smooth and convenient when implementing new regulations on extending drug registration numbers and expect to be able to apply this new regulation to submitted renewal applications, to ensure continued effectiveness from January 1, 2025 and avoid supply disruptions.

Vietnam aims for the pharmaceutical industry to contribute over 20 billion USD to GDP by 2045. The draft Pharmaceutical Law proposes policies to attract investment in research and development of technology, production of pharmaceutical substances, new drugs, and vaccines.

Source: https://thanhnien.vn/giam-thoi-gian-tham-dinh-ho-so-tang-co-hoi-tiep-can-thuoc-vac-xin-moi-185241003101908887.htm