Since January 1, 2026, the National Medical Products Administration's new export certificate rules have taken effect, as reported by NMPA Announcement No. 113 (2025). The key provision: drugs manufactured to GMP standards – even if not yet approved for domestic sale – can now obtain export certificates, removing a major bureaucratic hurdle.
This is particularly significant for companies like FS Pharma that focus primarily on exports. Previously, we had to navigate complex domestic approval processes even for products destined entirely for overseas markets, adding years of delay. The new rules cut through that red tape.
FS Pharma Perspective: This policy change is transformative for our product pipeline. We can now introduce new biologicals and formulations to emerging markets faster, without waiting for domestic registration. Our GMP certifications already meet international standards – this rule validates our compliance efforts. The 2026 Government Work Report naming biomedicine an "emerging pillar industry" further signals strong state support. We are already leveraging this to accelerate registration of our hepatitis vaccines in several African countries.
Combined with RCEP tariff reductions and regional procurement platforms, this policy significantly lowers barriers to entry, especially in ASEAN and Central Asian markets.