ASEAN Joint Assessment Procedure Prioritizes 11 Diseases

JAKARTA, Indonesia – The National Medicines Regulatory Authorities (NRA) of the Association of Southeast Asian Nations (ASEAN) have developed a new procedure for joint marketing authorizations, the ASEAN Joint Assessment Procedure.

Through the Procedure, the same marketing authorization application is simultaneously submitted to all participating NRAS, which includes regulatory agencies from Indonesia, Thailand, Malaysia, Singapore, Philippines, Vietnam, Brunei, Myanmar, Cambodia, and Laos.

Each individual regulatory makes a decision on the medicine under question through their normal, national-level decision-making process based on the joint report.

According to ASEAN’s NRA, the primary purpose of this endeavor is to strengthen the technical capacity of NRAs under ASEAN and to foster mutual trust and reliance among ASEAN Member States (AMS). Through this cooperation, it is hoped that pharmaceutical products will meet quality, safety, and efficacy requirements, and regulatory manners will need to be conducted timely and efficiently, building a network of collaboration among these countries

At the same time, the joint assessment procedure is being utilized to facilitate priority review of medicines in ASEAN markets, while respecting national-level decision-making processes.

Now that the pilot, which was kicked off in July 2017 and advised technically by the World Health Organization (WHO), has wrapped up, ASEAN NRAs have published a list of 11 priority products for their next joint assessment.

The focus of this next joint assessment is primarily on medicines for HIV/AIDS and hepatitis.

Included on the list are:

1. Products containing new active substances to treat Hepatitis C
2. Products containing new active substances to treat specific cancer, such as breast and lung cancers
3. Products containing new active substances to treat HIV/AID, such as efavirenz tablets 600 mg
4. Products containing new active substances to treat TB infection
5. Products containing new active substances to treat Hepatitis B
6. Products containing new active substances to treat Treatment-Resistant Depression
7. Products containing new active substances to treat general pustular psoriasis
8. Products containing new active substances to treat interstitial lung disease
9. Products treating chronic kidney disease
10. Products containing new active substances to treat Crohn’s disease
11. Products containing new active substances to treat Alzheimer’s disease

As noted in the statement from ASEAN NRAs, the treatment of Hepatitis C is a national priority, followed by gaining access to new treatments for cancer and chronic conditions. And in all cases, the NRAs are on the look out for the most effective treatments, with new mechanisms of action (as with the treatment of Crohn’s disease), which if proven to be of high quality, can be qualified as priority products.

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