WHO collaborative procedure for registering medicines through reliance

Marketing authorisation holders can apply to make centrally authorised products available in countries participating in the World Health Organization (WHO) collaborative registration procedure, which is based on the principle of reliance. The procedure involves sharing assessments carried out by the European Medicines Agency (EMA) with those countries to streamline the approval process of medicines.

Faster regulatory approvals allow patients to have earlier access to safe and effective medicines.

The collaborative registration procedure is a mechanism that promotes cooperation and information-sharing among regulators, to improve the efficiency of regulatory processes at a global level.

It also fosters the alignment of data-requirements and decisions in different regions of the world.

The procedure applies the concept of reliance to facilitate the assessment and approval of medicinal products by national authorities with limited regulatory resources.

National authorities can rely on a medicinal product evaluation already carried out by a recognised trusted regulatory authority, such as EMA, to approve or refuse to authorise a medicinal product within its jurisdiction. The decision-making process is fully independent.

The use of reliance allows participating countries to reach a robust regulatory decision more quickly than otherwise possible, within 90 days.

Marketing authorisation holders for centrally authorised products may share detailed assessments carried out by EMA with the national authorities concerned. This includes full final assessment reports and inspection reports, which are not publicly available.

EMA's European public assessment reports are also available as a basis for reliance.

Participation in the WHO collaborative registration procedure is voluntary. WHO supports and monitors interactions between all parties involved.

Scope and benefits for participants

All centrally authorised products are eligible for the WHO collaborative registration procedure. 

The WHO collaborative registration procedure enables marketing authorisation holders for centrally authorised products wishing to make their medicine available in a participating country to:

• Obtain faster regulatory approval
• Submit the same product dossier to one or more participating countries
• Avoid national inspections of manufacturing sites and laboratories prior to approval
• Reduce overall administrative burden

The procedure also brings multiple benefits to regulatory authorities by:

• Facilitating shorter timelines for registration
• Reducing duplication of efforts
• Fostering collaboration between regulators
• Promoting capacity building
• Releasing resources for other critical areas, such as post-market surveillance, monitoring, and regulatory oversight of medicinal products not yet approved by other regulators

These advantages ultimately benefit public health by making medicines more readily available to patients in the destination countries. 

Patients can also trust that EMA has approved the same products that are available at national level.

More information and list of participating countries:

• WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action?
• World Health Organisation - Accelerated registration of finished pharmaceutical products approved by SRAs

Interacting with EMA

EMA becomes involved in the WHO collaborative resgistration procedure at the request of a marketing authorisation holder.

National authorities need the following documents to evaluate the medicinal product:

• Product dossier used for EMA's assessment, submitted by the marketing authorisation holder
• EMA's assessment reports and inspection reports, provided by the WHO
• The quality information summary, validated by EMA and provided by the WHO

The quality information summary contains the main quality characteristics of the medicinal product and it allows confirmation of product sameness.

The marketing authorisation holder must ask EMA to validate that it contains the same information as that used for EMA's assessment, by sending an email to:

• [e-mail]

WHO shares the assessment reports, inspection reports and quality information summary with the national authorities through a secure platform.

The guidance below contains the necessary forms to submit requests to EMA (see appendices 3A, 3B, 4 and 8):

• Fifty-second report, WHO Technical Report Series, No. 1010, 2018 Annex 11: Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities