Changing Regulatory Requirements – Part 1 - European Union

EU 2011/62 Falsified Medicinal Products Directive and Product Quality

For the pharmaceutical industry, regulations always seem to be a moving target.  As the industry changes and market challenges occur, legislators demand accountability and pass laws for regulators to enforce.  Over the past two years, new legislation in the European Union and the United States have placed new demands and requirements on the industry and industry suppliers.  How regulators will enforce these laws and the impact on industry will be interesting to watch in the coming year.  This will be a multipart blog to examine these new laws and their potential impact. 

First up: EU 2011/62/EU Falsified Medicinal Products Directive.

This directive from the European Union is not a new law, but an update to an older regulation.  While the primary focus is on preventing or minimizing the problem of counterfeit and “gray market” drugs, there are requirements that will impact pharmaceutical companies, their suppliers, contract manufacturers and distribution networks.   It requires manufacturers of drugs and any active substances and excipients used to make final products that will be sold within the EU to follow Good Manufacturing Practices (GMPs).  All of these companies are now subject to inspection by the competent authorities of the member states.  These requirements apply to any company inside or outside of the EU, as long as their product or ingredient is used within a product sold in the EU.

Not only must all of these companies manufacture using GMP processes, the finished pharmaceutical manufacturers are required to have written confirmation that  the company has verified GMP compliance by its suppliers.  This written confirmation should be done through an audit of the supplier.  The regulation further spells out that those suppliers are not allowed to self-audit, or order a third party audit as proof of compliance.  In addition, pharmaceutical manufacturers are required to report to the competent authority within their state if their audit finds a supplier to be non-compliant with GMPs.  The regulation also states that the competent authority of a member state may carry out inspections of material manufacturers and suppliers at the specific request of the manufacturer.

All manufacturers, importers and distributors of final products or active substances or excipients for products sold within the EU must register with the competent authority in the country where the product will be marketed.  These organizations must register at least 60 days prior to commencing activity, and authorities may require an inspection prior to that activity commencing.  Companies are required to report changes annually, unless a change might impact quality or safety which would require immediate reporting.

The regulation states that manufacturers, suppliers, importers and distributors doing business or having their products or ingredients used in any drug sold within the EU “must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities.”

Let’s examine the potential impact on the pharmaceutical companies that do business in the European Union.  The first thing is to make sure the organizations they are doing business with have registered with the competent authority in each state.  The second thing is to assure that the audits of manufacturers, suppliers, importers and distributors are being performed and properly documented according to regulations and corporate standard operating procedures (SOPs).  If they are purchasing from an importer, is there visibility into what company actually manufactured the product, and did that company follow GMPs in that process?  Has the company put a system in place that assures audits are performed as required and follows regulations and requirements?  If a company has sites in or provides product or ingredients to multiple states, have they set up an efficient system for sharing audits, findings and information, or is each site working independently?  Bringing your audits together in a shared system can help a company create efficiencies by eliminating redundant processes and allow for faster onboarding of suppliers that may have already been qualified by another group from your company.

If you are a manufacturer of materials being used to supply EU pharmaceutical companies, have you registered your company with the local EU competent authority?  Do you have a quality system in place?  Can you withstand a GMP audit?  If not, you need to analyze your deficiencies and put in place systems that will ensure GMP quality compliance.   

The end result is that companies can be in control of their quality processes and can lower costs due to continuous improvement, not just due to regulations.  When quality is an important part of a company’s culture, they are enabled to create internal efficiencies that help eliminate the cost of poor quality, and will be trusted to provide safe and effective products.

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