[China Pharmaceutical Network Industry News] This is a mechanism to promote the export of more than 400 million doses of Chinese JE vaccine. It is also the most worthwhile global health professional technology platform in China. It is also a low-cost and efficient Chinese medical and health product that benefits the developing countries to the greatest extent. The path of the people.

This is the pre-certification project for medicines, vaccines, in vitro diagnostic reagents and medical devices established by the World Health Organization in 2001.

For Chinese pharmaceutical companies, obtaining WHO pre-certification is equivalent to obtaining “ticket tickets” from UN agencies, international organizations and some countries for medical procurement, which will help to enter the broad “blue ocean” of the healthy markets of developing countries around the world.

International pharmaceutical procurement has standards

Addressing the challenges facing today's global health sector, developing countries need safe, reliable, high-quality, affordable pharmaceutical products, including vaccines, pharmaceuticals, and diagnostic tools.

Every year, international procurement agencies such as UNICEF, the International Drug Purchase Facility, the Global Alliance for Vaccines and Immunization, and the Global Fund to Fight AIDS, Tuberculosis and Malaria are purchasing low-cost multi-billion dollar pharmaceutical products for aid development. The country's pharmaceutical market helps them cope with outbreaks of major outbreaks and epidemics.

The regulatory standards for pharmaceutical products vary from country to country, and market access is different. How to ensure the quality, efficacy and safety of international pharmaceutical procurement, and quickly promote the procurement of products into the market? The World Health Organization has set up a pre-certification project.

As the only global medical product quality assurance program, products that have been pre-certified by the WHO will be listed on the pre-certified product list, becoming an important indicator for reference and guidance in international pharmaceutical procurement. To address the public health issues facing developing countries, pre-certified products include medicines for the treatment of AIDS, malaria, tuberculosis, influenza, diarrhoea, tropical diseases and cancer, as well as reproductive health medicines.

Boosting Chinese medicine to the world

China's annual vaccine production and raw material drug production capacity ranks first in the world, and it can produce 1,600 raw materials. Wu Wenda, deputy director of the Beijing Representative Office of the Bill & Melinda Gates Foundation, said: "There is still a huge global health market demand outside of China. Chinese pharmaceutical products have great potential to benefit the world while meeting domestic demand."

The pre-certification of the WHO has set up a bridge for Chinese pharmaceutical products and innovation to the world.

In 2011, China's State Food and Drug Administration's vaccine regulatory system was verified to be in compliance with WHO standards, and Chinese vaccines were pre-certified.

In 2013, China Biotechnology Group Corporation JE vaccine became the first pre-certified vaccine in China. To date, more than 400 million JE vaccine preparations have been sold to countries and regions outside China. The Chinese flu vaccine also passed pre-certification in 2015. At present, the bivalent oral polio attenuated live vaccine, yellow fever vaccine, tetravalent meningococcal polysaccharide vaccine and hepatitis A vaccine from China are also in the pre-certification process.

As of July 2017, the WHO pre-certified 22 finished products from Chinese manufacturers and 4 in vitro diagnostic reagents from China.

For medical devices, Arktek's pre-certified Arktek refrigeration equipment can save vaccines for up to 35 days or more using ice cubes without any external energy, solving the problem of poorly stored vaccines in poor areas due to lack of electricity. In particular, it can play a role in vaccination work in sub-Saharan Africa.

Chinese medicine should be difficult to advance

Obtaining WHO pre-certification is not an easy task, and manufacturers need to go through many steps and rigorous review, and the cost of meeting pre-certification standards is high. The Chinese medical community facing challenges should be difficult to advance.

China is the birthplace of the antimalarial artemisinin, and it is responsible for the production and supply of more than 70% of the world's artemisinin raw materials. However, China's pre-certified artemisinin producers only have Guilin South Medicine.

Tang Wei, an official of the Expanded Immunization Planning Group of the WHO Representative Office in China, believes that the difficulty in applying for pre-certification by Chinese pharmaceutical companies is mainly reflected in the difference between domestic registration requirements and pre-certification requirements. Domestic pharmaceutical companies have limited ability to develop overseas markets. The gap between the quality level of domestic pharmaceutical products production and international standards and the gap between language and communication skills.

"Improving the level of production management and quality management and improving the level of supervision is the direction we always need to pursue." Tang said.

Original title: WHO "ship ticket" to help Chinese medicine go to the world

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(Source: People's Daily Overseas Edition (Beijing))