The ways of working across the globe continue to change. Emerging markets are starting to flourish and play a more significant role in global economics and there are growing demands for more localized control, rather than taking direction from more centralized, global influences. Consequently, maintaining balance in this glocal world is becoming complex. In this article Rossana Della Ventura, Site Compliance Manager at Pfizer’s Ascoli facility, describes how glocal demands are influencing pharmaceutical regulatory practices and advises on how to ensure consistency and quality of service are mantained for the benefit of patients.
Regulatory Challenges
The number of emerging markets across the globe is growing. There are greater expectations and demands within these territories for localized control over healthcare product regulatory and compliance practices rather than utilizing global, harmonized regulations such as those from the World Health Organisation (WHO). The implications within the pharma sector of this trend on the regulatory control of global supply chains and new product launches is significant.
Examples which illustrate the changing global pharmaceutical regulatory and compliance practice include:
- Brazil issuing a new resolution to move away from harmonized WHO regulations1
- China's Pharmacopeia 2020, which has had a significant impact on routine global supply
- The establishment of the Eurasian Economic Union (EAEU) and the new EAEU Pharmacopoeia2
There are now ongoing challenges in balancing the localized regulatory and compliance requirements with global supply expectations and logistics. As we look towards new launches and post approval changes, success depends on adopting the best approach for managing specific emerging market Board of Health (BoH) requirements.
Strong Communication
To manage the balancing of localized versus global regulatory requirements, it is crucial to build strong relationships and good communication between regulatory teams across the globe while ensuring full transparency in exchanges. Where there is any uncertainty or ambiguity, everyone should feel free to ask questions and clarify requirements.
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It is also important for all parties to recognize and acknowledge that the same ultimate purpose is shared – delivering safe and efficacious medicines to patients in need.
Global New Product Launch
New product launches and post approval changes need to be managed with great care, particularly when simultaneously dealing with multiple regulatory agencies and various requirements. A holistic approach is required when devising a regulatory strategy for a product launch or post approval change that considers all organizations and stakeholders. All parties should be consulted during the process and involved in executing the plan.
Consideration also needs to be given to ensuring timely supply of medicines to patients without risking disruption to the supply chain.
Looking Ahead
Adoption of common practices which satisfy both global and localized demands is a logical way forward, perhaps leading to a universal regulatory language. As a multinational organization with established networks and processes around the globe, Pfizer is well prepared for the regulatory changes associated with this ‘glocal revolution’.
Regulatory complexity in a glocal enterprise world could present a risk to the successful launch of new products due to the latest trend in emerging markets regulations. Adopting a science-led approach based on robust product knowledge management and risk assessment practices could help mitigate risk of delays and failure. The ability to manage changes, complexity and diversity in regulatory practices will be a fundamental factor for success within the regulatory field.
Regardless of any changes in industry culture and practice, the shared priority is to maintain focus on the patient and on the importance of product safety and quality.
References
- Huynh-Ba, K. and Sass, A.B. ANVISA: an introduction to a new regulatory agency with many challenges. AAPS Open (2018), 4, Article number: 9
- http://www.eurasiancommission.org/en/nae/news/Pages/30-12-2019-3.aspx