Today, we live in a world where international boundaries are no longer obstacles to communication, commerce or cooperation. The latest advances in medical devices and pharmaceuticals that save lives and enhance the quality of life are developed and marketed in numerous places around the world. People across the globe are increasingly aware of the issues and products that affect their health and well-being.

Our global community is enmeshed in complex regulations. Understanding this complexity and leveraging knowledge have never been more critical.

Harmonization, as it relates to the medical device and pharmaceutical industry, means the elimination of country-specific regulatory hurdles and the convergence of regulatory practices to create a uniform international regulatory environment for medical device and pharmaceutical industry worldwide. Ultimately, harmonization would simplify market access for medical device and pharmaceutical manufacturers around the world. The resulting improvement in the transparency of global regulatory requirements would expedite access to novel technology and enhance the assurance of device/drug safety.

Regulatory submissions in the pharmaceutical–biotechnology and medical device industry comprise documents and data that are submitted to a regulatory agency to gain approval to market new drugs, biologics and devices. The documentation represents years of research and includes multi-disciplinary information (including preclinical and clinical data) regarding the safety and efficacy of the product. The regulatory process varies from country to country and involves numerous interactions between the submitting company and the regulatory authority.

The development of a common submission format assemble registration dossiers in multiple countries, there has always been an incentive to promote as much similarity as possible in their form and content. Certainly there is now a single dossier format that is generally used in EU countries, and this has also been adopted to some extent by countries such as Canada and Australia. Manufacturers therefore no longer have to prepare completely different versions of the same dossier for each authority, although there are still country-specific requirements.

Many regulatory agencies accept electronic submissions in conjunction with or in lieu of submitting paper.

Regulatory agencies all over the world should share information and establish harmonized processes in the interpretation and application of technical guidelines and requirements for product registration, thereby reducing duplication of testing and reporting carried out during the research and development of new products. This trend has not yet resulted in faster product approvals, but global filling of CTD applications is becoming more common for both large corporations and small to medium-sized business. As the pharmaceutical industry becomes more familiar with the universal nature of most regulatory processes and takes advantage of business incentives offered by different locations, a corresponding reduction is expected in the time from bench to market for most products.


• Global Regulatory Scenario
• Harmonization
• Need for Harmonization
• Benefits/Obstacles
• Regulatory Submissions
• Guidelines & Objectives
• Common Contents
• Mode of Submissions
• Facilitating Submissions for Global Market Access
• Way Forward