Simplified Global Drug Approvals: Introducing the Access Consortium

The Access Consortium is a group of regulatory authorities worldwide who have come together to streamline the drug approval process. It consists of the Therapeutic Goods Administration in Australia, Health Canada, Health Sciences Authority in Singapore, Swissmedic in Switzerland and the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. The consortium aims to reduce duplication of effort and speed up the approval of new medicines by allowing pharmaceutical companies to submit a single application to multiple regulatory authorities simultaneously.

Key features

One of the key features of the Access Consortium is the work-sharing process, which allows regulatory authorities to share the workload of reviewing applications. Under this process, each regulatory authority is assigned a specific area of expertise and is responsible for reviewing that part of the application. This means the workload is spread among the different regulatory authorities, which helps speed up the approval process.

Submitting applications via the work-sharing process is a straightforward process. Pharmaceutical companies submit their applications to the regulatory authority in their home country, which then coordinates the submission to the other regulatory authorities in the consortium. The regulatory authorities then review the application and provide feedback to the pharmaceutical company.

Streamlining Drug Approvals: Collaborative Work-Sharing

The benefits of submitting applications via the work-sharing process are clear. Pharmaceutical companies can save time and money by submitting a single application to multiple regulatory authorities simultaneously. This reduces the need for duplicate testing and documentation, which can be costly and time-consuming. Additionally, the work-sharing process allows for faster approval times, which can benefit patients waiting for new treatments.

Streamlined Approvals: The Access Consortium’s Impact on Drug Development

In conclusion, the Access Consortium and the work-sharing process are important initiatives helping streamline the drug approval process. By allowing pharmaceutical companies to submit a single application to multiple regulatory authorities simultaneously, the consortium is reducing duplication of effort and speeding up the approval of new medicines. Additionally, the work-sharing process makes the approval process faster and more efficient by spreading the workload among the different regulatory authorities. This benefits patients waiting for new treatments by allowing them to access new medicines more quickly. Overall, the Access Consortium and the work-sharing process are important developments in the pharmaceutical industry that positively impact patients’ lives.

Insights into a recent Consortium project shared by a PLG expert.

Recently PLG was involved in submitting data in Switzerland, Australia and Singapore on behalf of our client, creating an opportunity for us to drive the initial registration of their product in the Australian market. Here are some of the insights shared by one of our experts:

“It was quite an amazing learning experience in a very short time,” PLG Regulatory Affairs Expert

Some of the tasks PLG performed are listed below

• PLG’s management of internal resources to create and review the module 1 documents.
• We provided feedback on labelling/artwork.
• Prepared and submitted the Pre-Submission Planning Form (PPF).
• Participation in weekly stakeholder meetings (Client, Consortium, PLG).

Benefits obtained from the work-sharing process

• Managing activities considering timelines and quality so that there is no need to rework and avoid duplication, saving time.
• Entire teamwork is the key to achieving this- focusing mainly on solutions rather than issues.
• Helped keep the team aligned and the deadline achievable.

The future of PLG as a life science service provider

The news of this Access Consortium is very exciting for ProductLife Group. This international collaboration harmonises with PLG’s outlook on supporting our global clients. We, as a company of life science professionals, remain committed to growing our skills, expanding our networks and providing superior client services to all our partners. Join us in this commitment and grow as we do.