Regulatory Context

A medicinal product is any substance or combination of substances presented as having properties for treating or preventing disease in human beings or which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
No medicinal product may be placed on the market of a European Union (EU) Member State unless a marketing authorisation has been issued by the competent authorities of that Member State or an authorisation has been granted in the EU.

flowchart sectors pharmaceuticals

Current issues in this Sector

Managing regulatory compliance
All stages of the product life-cycle, from research and development through manufacturing and marketing of products are governed by multiple regulations both at national and European (EU) level and the number of regulations are ever increasing. Non-compliance can cost a company money due to fines, recalls, audits and more.

Clinical trial data and transparency
Transparency is currently part of the requirement from the EMA requiring sponsors to publish Clinical Trial Results as a summary of the CSR. Already some European Agencies like the MHRA are replacing CSR submission with this requirement. This will become a mandatory requirement under the new European Clinical Trial Regulation.

Ensuring end to end visibility through the supply chain
Under the Falsified Medicines Directive, there is an increased need to ensure that supply chains are rationalised and transparent, in order to prevent counterfeit medicines from getting into the supply chain. Measures currently resulting are a requirement for registration of companies trading in active pharmaceutical products and a requirement for registration of brokers who are procuring pharmaceutical products.

Difficulties to be Avoided

Unexpected questions cause delays
Questions can be received from authorities during any review procedure. Questions during assessment of Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and variations can cause delays to approval timelines. It is important that areas of weakness in an application are identified in advance so responses to questions can be prepared in advance of receipt to reduce the clock stop time to a minimum.

Paediatric development
Since the Paediatric Regulation has been implemented it has been a requirement for companies to submit a Paediatric Investigation Plan (PIP). An agreed PIP decision must be available before a MAA can be validated. Many companies are leaving submission of a PIP until quite late in development. This can cause delays when the EMA requires further development of a product in paediatrics before a licence can be gained. The EMA does not want to delay licences.  However, it will not look favourably on companies who have delayed submission of their PIP.

Compliance issues during inspection
To avoid compliance issues, companies rely on experienced compliance teams to provide oversight from the earliest research and development to the very end of the product lifecycle. Best practices and processes need to be implemented in order to maintain compliance.

The most efficient route for your regulatory approval

Real Regulatory has up-to-date knowledge in key therapeutic areas throughout the product lifecycle and can assist you in dealing with current issues in drug development and in anticipating costly delays your application might encounter.
Our highly experienced team of consultants can ensure you follow the most efficient route to regulatory approval.

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