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Exclusion of pangolin formulae in the 2025 Chinese Pharmacopeia does NOT end the exploitation

On 25 March, the National Medical Products Administration of China announced the release of the 2025 edition of the Chinese Pharmacopeia, to be implemented from 1 October this year.

The release generated much fanfare because this latest edition removed 13 formulae which include pangolin in the ingredients.

Sounds good! But don’t be fooled by the headlines …

The removal of pangolin-containing formulae from the Chinese Pharmacopeia is definitely a positive development for pangolin protection efforts in line with recommendations of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and is welcome recognition of the need for change from the traditional Chinese medicine (TCM) sector.

Traditional Chinese medicine product made with pangolin, via yaozs.com

Pangolin scale TCM product

However, in practice it changes nothing in terms of what can be legally produced, nor does it offer any hope for other species such as leopards, for which formulae using leopard bone are still endorsed in the 2025 Pharmacopeia.

The Pharmacopeia is not a law, hence it has no regulatory power over what treatments can be registered and marketed.

In China, just as in the UK and the US, the Pharmacopeia is a collection of authoritative official standards for pharmaceutical substances and medicinal products. The approval process for new and generic drug registration and marketing would include a review of the manufacturer’s compliance with the Pharmacopeia but the Pharmacopeia itself does not dictate whether a new drug can be registered or not.

Consequently, the Chinese Pharmacopeia is not an exhaustive list of what medical ingredients and products are available on the market.

Should you wonder if a pharmaceutical company can apply to start manufacturing a formula excluded in the 2025 Pharmacopeia, the answer would be yes, because the standards set out in the previous Pharmacopeia still apply.

The only scenario where this changes is if China revises its laws or issues a notice to explicitly ban the use of a species.

The removal of 13 formulae containing pangolin from the 2025 edition of the Pharmacopeia has no legal impact. What can and cannot be registered is regulated by the Medicinal Product Administration Law of the People’s Republic of China. Article 28 of this Law stipulates the function of the Chinese Pharmacopeia as the national medical product standard and that substances and products can be registered and manufactured as long as they comply with the general medical quality standards approved by the State Council.

The main objective of the 2025 Chinese Pharmacopeia is to ensure items included in the Pharmacopeia are “commonly used in clinical practice, with definite efficacy, safe use, mature technology and controllable quality”.

The main impact of changes in whether a formula is listed in the Pharmacopeia is the social recognition of the clinical importance and quality of the medicine, as well as potential impacts on the coverage of national basic medical insurance.

Hence, the removal of the pangolin formulae from the Pharmacopeia can have positive impacts on social and behaviour change and demand-reduction efforts.

 

What is EIA is doing to address the exploitation of threatened species for medicinal purposes in China?

TCM manufacturers must ensure they comply with other laws and regulations applicable. This includes the China’s Wildlife Protection Law (WPL). EIA has long voiced concerns that the WPL retains exemptions which enable the breeding and utilisation of threatened species, including those under the highest level of Special State Protection such as pangolins and leopards.

We continue to campaign for the amendment of the WPL and to engage with stakeholders to deter investments in the use of endangered wild animals in medicine.

Another goal of the Chinese Pharmacopeia is to align the medical product standards in China with international standards, including collaborating with the World Health Organization (WHO) to harmonise standards and take the international lead in setting TCM standards.

It continues to be one of EIA’s key campaign targets to persuade WHO to explicitly reject the use of threatened species in medicine, to protect the iconic but exploited wildlife vital for a healthy world for all to live in.

Our latest letter to WHO – co-authored with Stichting SPOTS and IUCN Netherlands, with 99 other conservation organisations signing on – calls for amendments to the draft global traditional medicine strategy (2025-34) to reject the use of threatened wild animal species in traditional, complementary and integrative medicine.

The draft strategy is scheduled to be discussed at the World Health Assembly in Geneva for 19-27 May 2025.