National Healthcare Security Administration (NHSA) protocols

On 4 July 2023, the National Healthcare Security Administration (NHSA) published the drafted ‘Protocol for Renewal of NRDL Listed Drugs’ and ‘Negotiation Rules for Non-Exclusive Drug’. The two protocols aim to streamline the negotiation process for NRDL listed drugs and those with generic versions and are eligible for NRDL listing.

The renewal protocol has expanded the prerequisite of the 2022 version, enabling drugs that have been listed in NRDL via negotiation for more than 8 years (since 2015) to be automatically included in the regular List B.

This means that Multinational Company [MNC] products including Iressa (gefinitib) from AZ, and Viread (tenofovir disoproxil) from GSK, and domestic product icotinib from Betta Pharma will be eligible for this quick listing into regular NRDL in 2024. More products including Revlimid (lenalidomide) from BMS, Lucentis (ranibizumab) from Roche and Afinitor (everolimus) from Novartis will also be eligible for this renewal short-cut since 2025.

For the drugs has been listed in NRDL via negotiation for less than 8 years but more than 4 years, if the listing price will be reduced due to renewal or indication expansion, then the price drop should be cut in half. The negotiation process for non-exclusive drugs remains relatively unchanged as compared to the 2022 protocols.

You can read details of the news through the link below:

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National Healthcare Security Administration (NHSA) protocols
National Healthcare Security Administration (NHSA) protocols

Implication: After the protocol for NRDL renewal, price reduction pressure of MNC pharma companies in China would be eased to some extent. Before the policy, MNC companies may fail to be listed in renewal NRDL listing due to insufficient price decrease or with considerable price decrease and limited margin. After the protocol renewal, the level of price reduction becomes more predictable, which further indicates that innovative products are encouraged in China market.

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