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Material Review Process

How to stay up to date with the complex and changing regulatory environment of drug promotional activity?

In the world of pharmaceuticals, every single aspect of production needs to be compliant, which is why the promotional material review process must follow a set of strict guidelines. The Medical, Legal and Regulatory (MLR) process is there to bring the risks inherent to the production of drugs down to a minimum. This includes ensuring that consumers are not misled by the product’s claims and have access to accurate facts about side effects, efficacy, and any other elements that may help them make an informed decision. Because of these stringent yet ever-evolving guidelines, it can be challenging for pharmaceutical companies to keep up with their obligations throughout the many steps of their products’ lifecycles.

The Promotional Material Review Process: A Necessary Step for Compelling, Compliant Product Information

Before we delve into why and how pharmaceutical companies should ensure that their promotional material review process is compliant with the current standards, let us define what constitutes this material. It includes any activity organized or sponsored by a firm intended to promote the consumption, administration, supply, recommendation, or prescription of a medical device, biotechnology, or pharmaceutical product. Various communication approaches, such as packaging, brochures, websites, mailings, presentations from medical representatives or spokespersons, and congress materials, fall under this category. For products to be sold in the EU, the content of this nature must follow EMA guidelines whether it is addressing consumers or medical professionals.

The EMA regulations are there to protect consumers and ensure that any product labels, ads, and information provided by their healthcare professionals are fully accounted for and vetted. The fact is, however, that it is difficult for pharmaceutical companies to stay on top of the MLR process specifications. Because it is only one part of their obligations and goals pertaining to their content management strategy and because it is constantly being modified, firms often end up in a situation of misalignment. When exporting pharmaceutical products for use in EU countries, they run into even more conflicting requirements and can easily begin to lose track of what is expected of them.

How Can Companies Ensure that Their Promotional Material Review Process Is Compliant with EU Regulations?

Fortunately, pharma groups can rely on external support to help them meet their objectives in terms of worldwide promotional material review and validation for medical devices and drugs. These regulatory and medical review services provide relevant, up-to-date advice and will make sure you remain competitive in this highly complex environment. Some even boast a worldwide network of strategic partners in the pharmaceutical industry, from training to full-blown project management.

As a pharma group, you can call upon them at the very start of a promotional campaign project or submit your content to them at the end for a final promotional material review. Whether you need support through the EMA application process or at any stage of your product or promotional content development, these specialists can help with any medicinal product launch activities. They provide clear and concise market feedback on the risks associated with promotional materials in the EU, as well as convenient alternatives to make your product compliant wherever you wish to distribute it.

Promoting pharmaceuticals is a necessary phase to ensure the success of any drug, whether it is intended to be sold in the U.S. or the rest of the world. Do not let the difficulty of the European promotional material review process intimidate you. With specialists by your side, you can have peace of mind when preparing your promotional campaigns and selling your products internationally. Whether you need help with your validation requirements on an ad hoc or an ongoing basis, you will be sure to remain compliant every step of the way.