Licensing a New Dosage Form
Having developed a unique new oral dosage form for a well-known over-the-counter pain management product, this small- to mid-sized EU-based pharmaceutical organization wanted to get its innovative product – which offered an enhanced proposition for adults and children – licensed quickly within the EU.
Looking to bring an improved and more user-friendly pain management drug to market to meet consumer demands, this organization had developed a chewable soft gel tablet which enabled active ingredients to be absorbed via the mouth and to be much more user-friendly for children
The new oral dosage form would expand the user base of this OTC pain management product by offering greater ease of use for people who find it difficult to swallow pills or tablets, especially children and young people. But with little experience undertaking new dosage form submissions, the organization knew it faced a challenge when it came to formulating and justifying its dosage approach to licensing authorities.
In today’s competitive development environment, reducing the time-to-market for this innovative commercial product was an important priority. To avoid delays, the organization needed to ensure it selected the most favourable route of assessment. That meant the provision of data for the new dosage form represented a crucial aspect of the submission process.
ELC Group solution
ELC Group’s experts needed to resolve the challenge of gaining widespread regulator acceptance of the new pharmaceutical form, building a case for use of the form in the pediatric population. ELC Group also needed to ensure it enabled opportunities for regulatory bridging, to ease the future introduction of the product into territories beyond the EU.
Before approaching EU regulatory agencies, the ELC Group team undertook extensive research to identify a comparable drug similar to the original, selecting oral dosage forms to undertake a preparation of the PK comparison in the clinical study. This would support the preparation of submission justifications for the new dosage form, an approach that would minimise the risk of time-consuming potential feedback from licensing authorities.
Once this approach was underway, ELC Group next approached EU agencies it had identified as having experience of change of dosage forms. Using input from these agencies, ELC Group was able to define a hybrid generic filing strategy together with an RMS.
ELC Group prepared a clinical comparison approach, supported by a series of short PK studies to demonstrate bio-equivalence and avoid a full clinical efficacy program. This would save the pharmaceutical organization considerable additional time and cost investments.
The ELC Group solution included:
- Selecting the most favourable route of assessment.
- Development of a Regulatory Management Strategy (RMS), following advice from Agencies.
- Selecting appropriate comparable products for the clinical bioequivalence study.
- Construction of a comprehensive justification data presentation for the new dosage form.
- Evolution of a regulatory and clinical strategy, involving complex bridging of several PK studies to avoid a full clinical efficacy program.
- Rework of the clinical overview to rebut the potential deficiency of clinical question.
- The new product is now successfully licensed across the EU, without any need for full clinical studies.
- ELC Group experts undertook the complex bridging of several PK studies to support expansion into markets beyond EU territories.
- ELC Group’s local teams pursued EU filings, refining the regulatory and clinical strategy for local country requirements.
- Markets in other global territories which accept EU filings are now being targeted for product introduction.