MNCs wait for clear drug registration to get ahead

MNCs wait for clear drug registration to get ahead /photo freepik.com

A representative of the Pharmaceutical Sector Committee of the European Chamber of Commerce in Vietnam has said that it can take 4-5 years for a new medicine approved in the EU/US to be available in Vietnam.

“Our members are facing delays bringing new medicines to market, constant risks of supply shortages, and continued challenges in operation (from the need to build significant inventories to bridge gaps if possible) because of complex regulations and delays in registration dossier review,” the representative said.

In fact, Vietnam requires specific requirements for documents and processes for drug registration that are different compared to requirements in ASEAN countries and globally. Furthermore, there is a lack of practical transitional measures between old and new regulations, and a lack of measures to synchronise approved administrative contents to relevant lists. Implementation, both in terms of process and resource, is not yet fully efficient and there is a significant number of backlogged dossiers.

Ngo Thanh Hai, senior associate of LNT & Partners, elaborated that Article 56.5 of the Law on Pharmacy 2016 sets the time limit for issuing market authorisation (MA) at 12 months from receipt of a full and valid application for new drug products and three months for renewal. “However, in practice, the time taken to obtain MA is usually more than one year. It is estimated that only 8 per cent of more than 2,000 new MA application dossiers were successful,” Hai said.

“Another challenge is that many MAs of medicines which are used in treatment of acute, chronic illnesses will expire and may severely affect the lives of many patients. It is estimated that out of over 1,000 renewal dossiers submitted, only about a quarter received approvals,” he admitted.

In practice, multinational pharmaceutical companies need 3-6 months to plan, manufacture, and import medicines to Vietnam, after receiving MA approvals from Vietnam’s Ministry of Health (MoH). Therefore, the predictable and timely review and approval of MAs is crucial for companies to make appropriate preparations, especially, in the present context where global supply chains are already stretched.

Vietnam currently falls behind ASEAN markets as it has the lowest innovative pharmaceutical share across the region. Innovative pharmaceuticals represent 20 per cent by value and approximately 4 per cent by volume, and the country’s innovative pharmaceutical registration timeline is among the slowest in the world.

In an effort to reduce the administrative burden on the management of drugs circulating in the market and speed up the dossier review progress, the MoH’s Drug Administration of Vietnam is in the process of building an e-registration system.

While waiting for the effective implementation of this system which requires time and resources, and actions from authorised agencies to solve the critical challenges, multinationals are boosting their footprints in the country, with one of the focuses being innovative medicines.

Amitabh Dube, country president of Novartis Vietnam, told VIR, “Key priorities for us in 2022 and beyond would be to reimagine medicine and patient care in Vietnam. We will focus on getting new innovative medicines in Vietnam and focus on clinical research and development in the country.”

Novartis has put a remarkable footprint in Vietnam of global clinical trials for 10 years with more than 50 studies and 1,000 local patients in various areas including oncology, ophthalmology, neuroscience, respiratory, dermatology, nephrology, cardio-metabolism, malaria, fascioliasis, and rare disease. There have been more than 130 investigational sites participating in these international multiple centre trials, and more than 1,000 healthcare professionals have been trained and experienced in conducting global clinical trials and carrying out good clinical practices.

At the Switzerland-Vietnam Business Summit in Bern in late November, Novartis and the MoH signed an MoU to provide affordable medicines without a profit margin for the treatment of severe COVID-19 symptoms.

November was busy for multinationals to announce new plans in the local pharmaceutical industry. AstraZeneca reached two landmark agreements with Vietnamese partners to enhance the local biopharmaceutical manufacturing industry and pandemic response in the country – one of them is the company’s extra investment of $90 million to develop Vietnam’s domestic manufacturing capabilities.

Elsewhere, Sanofi will expand in the Southeast Asian nation with the MoU signed with Vietnam Pharmaceutical Corporation. The former plans to add investment in domestic production and expand the scale of production plants for export. Specifically, Sanofi envisions a multi-year investment plan of up to $5.66 million to support the expansion of its manufacturing plant in Vietnam, along with localisation through technology transfer to Sanofi Vietnam.