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WHO Pre-qualification is an internationally accepted certification standard for drugs (including vaccines). It provides technical support for the procurement of quality-assured medicines by international public health organizations such as United Nations agencies. For pharmaceutical companies, obtaining pre-certification is equivalent to obtaining market access passes for multiple public purchasers at one time. At the same time, this is the gold standard for patients with high quality medicines in many countries and regions.

The WHO website publishes a list of pre-certified essential drugs and publicly invites global pharmaceutical manufacturers to submit pre-certification applications. Previously, WHO pre-certification was limited to the following treatment areas: diarrhea, AIDS, malaria, hepatitis, tuberculosis, influenza, reproductive system diseases, neglected tropical diseases, and vaccines necessary for immunization.

In recent years, a large number of biotherapeutics have successfully treated many life-threatening chronic diseases, such as cancer. In May 2014, the World Health Assembly adopted a resolution “including the accessibility of biotherapeutics for biosimilar drugs to ensure their quality, safety and efficacy”. The pre-certification of the two biopharmaceuticals (both cancer drugs) is of great significance.


Biotherapeutic drugs, including the corresponding biosimilars, are highly complex biopharmaceuticals, and for many countries’ regulatory and evaluation systems, such as the approval of such drugs in accordance with internationally accepted guidelines is a huge challenge. To promote access to biopharmaceuticals with guaranteed quality, safety and efficacy, WHO decided to explore the feasibility of pre-certification of such drugs to support countries in improving access and affordability of biopharmaceuticals. Previously, anti-cancer drugs such as imatinib have been included in the Essential Medicines List by WHO, and the pre-certification of open anti-cancer biopharmaceuticals means that cancer drugs are entering the basic field of public health.

The WHO pre-certification team has released a pre-certification path for two biopharmaceuticals and their analogues, inviting global pharmaceutical manufacturers to submit an “Expression of Interest” (EOI) to submit a pre-certification application to the pre-certification team biotherapeutic drug group.


The invitation is limited to two drugs and their biosimilars:


Rituximab: Roche’s rituximab for the treatment of non-Hodgkin’s lymphoma. Rituximab is a recombinant human mouse chimeric anti-CD20 monoclonal antibody targeted drug. Domestically, the rituximab injection biosimilar drug HLX-01 developed by Fuhong Hanlin for the treatment of non-Hodgkin’s lymphoma (CXSS1700026) has been accepted by the CNDA drug registration review.
Trastuzumab: Herceptin from Roche Pharmaceuticals for the treatment of metastatic breast and stomach cancer. Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that targets the extracellular site of HER2 (human epidermal growth factor receptor 2) and is the first macromolecular targeting in cancer therapy drug.

Two application channels for pre-certification:

  • Biosimilar drugs approved by non-SRAs and listed in a certain country must complete a full evaluation. The similarity evaluation included a head-to-head test comparing non-clinical and clinical complete data with a reference drug approved by a strict drug regulatory agency.
  • Biopharmaceuticals and their biosimilars approved by strict drug regulatory agencies can be pre-certified through bridging assessment.

At present, WHO adopts the 2015 document for the temporary definition of strict drug regulatory agencies (SRAs):

  • ICH members, including EU EMA, US FDA, Japan PMDA, or
  • ICH Observer, the European Free Trade Association (represented by the Swiss Food and Drug Administration), Health Canada (before October 23, 2015), or
  • Drug regulatory agencies that recognize each other’s legal procedures with ICH member states, such as Australia, Iceland, Liechtenstein, and Norway (before October 23, 2015)

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