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Executive Briefing - International Approval

A decision to enter a new market is often made quickly; the regulatory implications often don’t become apparent until later. This Executive Briefing shows how manufacturers can assess requirements, existing evidence, resources, and long-term commitments early on and use this information to develop a viable regulatory strategy.

Here's what you can expect

What a New Market Means for Your Business

This briefing helps you evaluate a planned market entry from multiple perspectives:

  • What questions senior management, sales, and regulatory affairs should address together before determining the market launch and allocating resources
  • How to assess which existing documentation can be used for the target market and where additional documentation is needed
  • Why product versions, documentation, and local requirements should be planned across multiple markets
  • What sequence of markets and submissions might be appropriate
  • What tasks remain after approval, such as changes, registrations, post-marketing surveillance (PMS), and pharmacovigilance


Prepared by Signe Neumann Gaspar, Expert in Regulatory Affairs & Technical Documentation, Metecon GmbH

executive-briefing_internationale-zulassung_metecon

Table of Contents

Four Perspectives on International Market Access

Assessing the Market Opportunity

An interested customer or sales partner provides a good opportunity to evaluate a market. The briefing outlines the regulatory and organizational questions that should be addressed before making a binding market decision.

Review existing documentation

EU documentation is often an important starting point. Whether it is sufficient for a specific target market depends, among other things, on that market’s requirements regarding classification, documentation, labeling, and quality management.

Prioritize Markets Wisely

Not every target market needs to be addressed individually and one after another. The briefing explains when it may make sense to conduct joint preparatory work, submit proposals in parallel, or postpone a market.

Provide Ongoing Support for Market Access

The work does not end with approval. Product changes, local registrations, deadlines, and PMS and vigilance information must still be taken into account even after the product enters the market.

International Approval

Questions About the Executive Briefing and Download

Does the Executive Briefing include specific regulatory requirements for individual countries?

The Executive Briefing provides a framework for planning international approvals. It explains how manufacturers can evaluate target markets, review existing evidence, prioritize submissions, and take ongoing obligations into account. It does not include a detailed overview of the regulatory requirements for individual countries. These must be reviewed for the specific target market and product in question.
Is the briefing also relevant for manufacturers who are already operating internationally?

Yes. As new markets are added, the tasks related to product versions, labeling, local partners, registrations, and changes also increase. The briefing helps senior management, Regulatory Affairs, Quality Management, and Sales to view these interrelationships across multiple markets and to incorporate ongoing support into future market decisions.
How do I get the Executive Briefing?

Fill out the form on this page. You will then receive an email with a link to the PDF. You can download the briefing, access it again later, and share it with your colleagues. If you don't receive the email, please check your spam folder.