Regulatory Affairs Management

Setting performance targets is an established practice for the pharmaceutical industry, enabling it to drive performance. At a time when it is common practice for medicines to be developed for a global market and companies are endeavouring to expedite the drug development process, Regulatory Authorities have also been concentrating in improving their efficiency and effectiveness. Up until now, for most authorities, this has involved only the streamlining of existing processes and resulted in marked improvements in approval times. In order for further developments to be made, authorities will have to evaluate extensively their processes.

Performance measures must reflect more than just speed. However, measuring quality is far more difficult. What systems can therefore be put in place to ensure consistency in quality across therapeutic areas within authorities and across national authorities? It is not surprising that questions are being asked as to how performance might be measured and compared between different authorities. Issues such as “what target should be set for the review of new drugs?” or “how can quality be assured?” are now considered to be of critical importance. These questions were addressed by those who are actively involved in ensuring the regulatory review system abide the authorities’ responsibilities to both the public and industry.

Dramatic changes are leading towards a different generation of pharmaceutical research and development, which will be global, outward looking and driven by technology, genetics and a variety of partnerships. Value for money will become the driver in the marketplace. However, drugs of tomorrow will be judged on their ability to increase value to the patient and the payer, both therapeutically and financially.

In such an environment, there will be a need for the skilful use of strategic targets and performance management. Not only will this generation of pharmaceutical research and development require a good understanding of underlying sciences and technologies, it will also demand a more fruitful and flexible collaboration between industry and regulators. This partnership should extend beyond very tangible business of new drug development to embrace mutual learning in the important business of defining and monitoring performance targets and learning from best practices.

Do you know how long it takes for a drug to be approved? It takes approximately seven to ten years to move a drug from compound identification to Phase I of clinical trials to approval by the FDA, so firms cannot afford to get it wrong at any step in the process. This is where strategic R&D advisors come in, empowering their customers with faster, more efficient and more profitable launches, following the rules imposed by regulation, and ensuring their growth.

While everyone understands the importance of developing new drugs, what is less well understood are the processes through which it happens. It is not enough to simply identify which roles contribute to firm success, effective strategy execution requires that managers help to consistently enable performance in specific positions and at specific times. To deliver on this master plan there are essential strategy capabilities such as product registration, sales and marketing studies, government relations, quality assurance, among others, which need to be called into action. By far, one of the most relevant organizational capability is in the domain of regulatory affairs.

Regulatory Affairs is a department in a pharmaceutical company which critical role is to ensure that its organization complies with all of the regulations and laws pertaining to product research, in order to delivery safe and effective healthcare products to individuals around the world. Their role is to develop and execute a regulatory strategy to ensure that the product is approvable by target market regulators but is also differentiated from the competition in some way, and also to ensure that company’s activities are conducted in accordance with regulations and guidelines established by regulatory authorities. The success of regulatory strategy is less dependent on regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents.

In this highly regulated environment, Regulatory Affairs play a critical role not only as the interface with health agencies and as a link between different departments in the company, but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug. They are involved in all stages of drug development, and after drug approval as well. The drug development process is a lengthy, complex and extremely costly albeit necessary process. Pharmaceutical companies use all the data accumulated during discovery and development in order to register the drug and thus market the drug. Throughout development stages, the companies have to abide by an array of strict rules and guidelines in order to ensure safety and efficacy of the drug in humans.

              Although specific challenges that regulatory professionals face vary, the phenomena that underpin have not changed over the years. Regulations change, leading to changes in regulatory guidelines; novel technologies evolve, leading to new regulatory pathways. Organizations look to regulatory professionals for more guidance and insight, so they must learn about new things quickly to successfully meet these demands. Increasing levels of globalization without concurrent regulatory harmonization also presents significant challenges.

The regulatory professional should have a mix of scientific knowledge, negotiation skills and business intelligence. But how much of it is really science, and how much of it is affairs? The answer could be simple, as suggested by EMA: ‘Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory standards and tools’. Therefore, a scientific discipline, but conducted within a legal framework.

In essence, even the most skilled regulatory scientist must work in a team of professionals with different backgrounds and knowledge to ensure a positive outcome and a scientific approach to regulatory intelligence. This, ultimately, is the key for success. This is where you should seek professional advice. Surround yourselves by a strategic advisory company with strong technical and strategic knowledge in Regulatory Affairs and Quality Assurance, duly certified in your target markets.