More than last two decades, the pharmaceutical market has undergone many significant changes and trends in terms of globalisation. Many pharmaceutical activities like manufacturing, R&D and supply chains are now global but besides all these efforts, the pharmaceutical products are mostly regulated nationally and many different local registration requirements are burden for the manufacturers. For this reason, a global regulatory harmonisation is becoming essential not only for manufacturers and other shareholders but also for the public interest as one of the aims of Universal Health Coverage (UHC) is giving the access to users high-quality and affordable health services.
The working on harmonisation can surely create many challenges but at the end, it will be ending by increasing efficiencies, reducing costs, enhancing R&D, and benefitting patients by improving safety, innovation and access.
So, what is standing in the way of global regulatory harmonisation?
This is an extract from What is standing in the way of global harmonisation? Part II: Industry Voices. Click here to read the full article.
Language barriers
Many different language barriers can cause obstacles for global regulatory harmonisation.
Within the scope of harmonisation, the regulations can be translated into local languages for the understanding of regulators and local manufacturers but there will be still some linguistic problems to handle. For example, translation of dossiers in local languages creates another workload for companies/sponsors. This requirement is also the reason of recreation of eCTD/NeeS files with translated leaf titles. As a result, this exercise comes out at higher cost and time loss for companies which affect the market access of products.
Lack of legislations and comprehensive websites in English of non anglophone countries’ agencies is another blocking point to understand the local requirements which obliges companies to move through local experts (affiliates, distributors, consultants etc.). The absence of global harmonised regulations at these regions can make understanding of local requirements even more complicated.
Once again, understanding is the key of effective communication which is possible by using a common language. Therefore, sharing experiences, learning from each other, constructive discussions without speaking the same language can be hurdle for global harmonisation. The difficulty for local regulatory agencies is not only about understanding global legislations but also product specific dossier review in English.
Lack of standardisation and autonomy of local regulatory bodies
Another reason standing in front of global regulatory harmonisation is coming from local regulatory bodies like the inconsistency in local regulatory requirements. Even in ICH follower countries, companies experience different dossier evaluation styles because of lack of standardisation for dossier review. This difference is more dominated in emerging countries which do not make assignment of specific evaluators. Even in many of these countries, a standard review time of 210 days is applied; companies still receive many questions caused by different judgments of evaluators resulting longer review timelines. Some non-written/communicated, dossier based or local requirements like additional stability studies, detailed documentation, SOPs, validation requests cause also longer approval period.
Other blocking points of harmonisation are the lack of resource and knowledge of regulatory bodies. Many developing country regulatory systems are not able to review effectively of every type of submissions. Especially for New Chemical Entity (NCE) submissions, adequate regulatory scientific knowledge is needed for assessment. Because of this lack of expertise and regulation, many developing countries highly rely on prior approval or supporting regulatory decisions of other “stringent” regulatory bodies like US FDA and EMA.
To overcome hurdles for global harmonisation, it is needed to gain knowledge, autonomy and enrich regulatory bodies’ organisation. Scientific skills are not always easy to gain by external trainings but by a deeper expertise with continuous learning. Even though this exercise sometimes requires having in-house and/or external experts which can add financial burden for government, it is essential to act nationally and even regionally with appropriate coordination and common will to help drug regulatory bodies having enough resource and skills.
Additional regional requirements
Surely each country weighs differently key factors such as risks and benefits, region specific diseases, vulnerable populations and financial concerns which enable a one-way model regulation harmonisation.
There are different needs by each country requiring some additional local studies like clinical trials or some population specific studies for neglected tropical diseases. These local requirements might be important obstacles in the design of randomised control clinical trials as the clinical pattern can vary from country to country.