The NMPA has issued its first list of rare diseases at the national level in May 11, 2018 that outlined the rare diseases in China to encourage research and development in those areas. Find attached the list in English.
As applicants for Rare Diseases can have the opportunity to decrease or lessen the number of clinical trials required to speed up the drug development process.
Recently, in December of 2020, the National Security Health Administration has also updated its annual list of drugs that are covered under the Basic Medical Insurance Plan. This gives hope to those that carry related diseases on the potential to be treated under those particular areas. There were a total pf 121 rare diseases released in 2018, including hemophilia, neurofibromatosis and others.
Rare Disease Drugs Eligible for Reimbursement under China’s Basic Insurance Plans
In 2021, Basic health insurance plans in China will start to cover the cost of most drugs used to treat rare diseases. Under the plan, rare disease drugs that are proven effective and that are not remarkably priced will be subject to review by experts.
The drugs approved after the review will be listed in the National Drug Reimbursement List (NRDL) and will be eligible for reimbursement coverage by China’s Basic Medical Insurance (BMI) and other insurance plans.
What is the NRDL?
The National Reimbursement Drug List is Updated every year, the list and determines what pharmaceuticals are eligible for reimbursement under the country’s national health insurance plans.
If similar drug products produced by a range of competitors and are deemed safe and effective, the review panel of NRDL regulators choose the pharmaceutical that is the least expensive to produce with a reasonable retail price.
To be included in the list, drug manufacturers must agree to cut prices on the medicines by at least 50 percent. However, drugs added to the list generally see a major boost in sales by Chinese customers.
NMPA: List of First Batch of Rare Diseases
The NMPA has issued its first list of rare diseases at the national level in May 11, 2018 that outlined the rare diseases in China
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China's NMPA regulates the registration of drugs, medical devices and cosmetics; as well as conduct strict review and approval for marketing of these products.