MHRA’s Guidance: Access, New Active Substance and Biosimilar Work-Sharing Initiatives

Sharan Murugan
16 hours ago
2 min read

In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients access innovative treatments faster while maintaining robust safety standards, the UK’s MHRA has introduced collaborative regulatory pathways: the New Active Substance Work-Sharing Initiative (NASWSI) and the Biosimilar Work-Sharing Initiative (BSWSI).

These initiatives enable pharmaceutical companies to apply for joint scientific assessments across several trusted international regulators, streamlining approvals without sacrificing thorough review.

What is NASWSI?

The New Active Substance Work-Sharing Initiative (NASWSI) allows marketing authorisation holders (MAHs) to submit the same dossier simultaneously to multiple participating regulators. These currently include:

MHRA (UK)
TGA (Australia)
Health Canada
HSA (Singapore)
Swissmedic (Switzerland)

The purpose: a single, coordinated assessment where each agency reviews specific parts of the dossier, shares findings, and collectively discusses questions before asking the applicant.

NASWSI only applies to new active substances (NAS), including new chemical or biological entities that haven’t previously been licensed in the UK or the other participating markets.

How it works in brief:

Applicants submit an identical eCTD dossier (except country‑specific modules like Module 1).
No rolling submissions – the full dossier is required from the start.
Each agency leads review of specific modules (e.g., quality, non‑clinical, clinical).
A consolidated assessment report is produced.
Final national decisions remain separate but based on the shared assessment.

What is BSWSI?

The Biosimilar Work-Sharing Initiative (BSWSI) is a parallel process focused on biosimilar medicines—products that are highly similar to an already approved biological medicine.

BSWSI aims to reduce duplication of effort, speed up assessment timelines, and enhance consistency across markets.

The operational steps are similar to NASWSI: a shared evaluation with national decisions still issued individually.

Assessment Procedure and Fees

📂 Applying

Applications are made directly to each participating agency under national procedures, referencing the NASWSI or BSWSI framework. A common assessment timeline is agreed among regulators.

⏱ Timelines

The MHRA’s target timeline for its share of NASWSI/BSWSI assessments is 210 calendar days. This compares favorably with standard timelines and aligns with international best practices.

💰 Fees

MHRA charges its standard national assessment fee. Separate fees may also apply to other participating agencies.

The MHRA’s NASWSI and BSWSI initiatives show the power of international collaboration to speed up access to critical new medicines while maintaining high regulatory standards.For pharmaceutical companies, these frameworks offer: