Answers around corner for market authorisation renewal

The Government Office on April 17 issued Document No.115/TB-VPCP after Deputy Prime Minister Vu Duc Dam chaired a meeting on the marketing authorisation (MA) renewal procedure towards revising the controversial rules in alignment with international practices.

In Document 115, Dam asked the Ministry of Health (MoH) to work with the General Department of Vietnam Customs to deal with the problems related to customs clearance procedures for imported drugs.

The MoH was also asked to work with the Ministry of Finance and then complete a draft decree guiding the implementation of Resolution No.12/2021/UBTVQH15, and report to the prime minister before April 20.

The MoH is requested to soon complete the amendment of Circular No.32/2018/TT-BYT on drug registration and MA in line with international practices, increasing state management efficiency, and cutting cumbersome administrative procedures to facilitate business activities.

In late 2021, the National Assembly Standing Committee issued Resolution 12, allowing some policies in the healthcare sector to help with pandemic prevention and control, and other activities in the field. The resolution enabled the continued use of MAs until the end of 2022 to serve diagnosis and treatment activities.

To implement the resolution, the government assigned the MoH to work with ministries and agencies on building a draft decree. According to the MoH, this draft was appraised by the Ministry of Justice (MoJ) on February 28, and the MoH is now collaborating with the MoJ and other relevant agencies to complete the draft and then submit it to the government for issuance.

Resolution 12 has been highly appreciated by the business community and could be a new ray of hope for multinational corporations in Vietnam. However, four months has passed and it is yet to be applied in practice, causing negative impacts on suppliers.

According to the MoH, at the end of 2022 nearly 9,800 MA numbers will expire. If the expiration date of June 30, 2022 is counted, more than 7,700 files were sent to the MoH for MA renewal, including over 5,600 files for domestically-made drugs and nearly 1,900 others for foreign-made ones, as well as another 235 related to vaccines and bio-products.

The MoH explained that the appraisal of files for MA renewal and other related works have faced many difficulties in the past two years. Worse still, many legal papers such as GMP standards and other certificates are yet to be renewed.

As planned, the sector would open large-scale tenders for the purchase of drugs in the first and second quarters at the national and provincial levels. Such a move has been delayed since June 2021 due to the pandemic, and if the to-be-expired MA is not renewed, distributors would find it difficult to register for tenders.

Industry insiders forecast that in the second half of this year, the healthcare sector is likely to face a lack of drugs if the barriers related to congestion of MA renewal files at the MoH are not solved.

Under the existing rules, pharmaceuticals and ingredients must get the MA from the MoH before being used in treatment or pharmaceutical production activities in Vietnam. The first MA provides a product with a registration number and validity of 3-5 years. After that, it will then have to be renewed for further use.

The MA renewal has been an issue of special concern for years. At the Vietnam Business Forum held in February, international business associations also once again raised this problem.

Alain Cany, chairman of the European Chamber of Commerce in Vietnam, said this measure should be implemented without the need for companies to wait for guiding regulations and without the need to carry out burdensome administrative procedures, which would go against the urgent spirit of the resolution.

“We seek the National Assembly and the government’s support in directing a shared understanding among relevant agencies for this measure to be implemented urgently and to be applicable to all medicines, not only those for COVID-19 treatment,” he said.

Likewise, a representative of the American Chamber of Commerce in Vietnam said, “We also support the revisions to Circular 32 to ensure appropriate amendments are made to the registration and MA of new and existing products. This will ensure continuity of supply of critical medicines and support enhancement of the pharmaceutical sector.”

Pharma firms expect the establishment of a mechanism for MA to remain valid throughout the product lifecycle, similar to the practice in other countries, instead of being subject to renewal every five years.