Twenty-first century challenges require 21st century solutions. This fact applies broadly in our current global economy, where many industries are looking beyond traditional, developed markets to the emerging markets. One such industry is healthcare, where medicines are used to extend and improve the quality of life for patients around the world. There is an increased need for consistent and appropriate quality requirements for medicines because disharmonized standards do not provide additional value or benefit, but rather increase the cost and complexity of bringing medicines to patients worldwide. Medicines may be globally sourced across developed and emerging markets, and the supply chain for ingredients and drug products is complicated by the overall lack of consistent, harmonized quality requirements.
The lack of harmonized drug standards is the result of several existing conditions, including national and regional laws, regulatory requirements and expectations, and applicable pharmacopeial (or compendial) requirements. Pharmacopeias with differing standards exist in many of the developed and emerging economies. The purpose of this paper is to initiate discussion on a new approach to address the challenge of achieving globally harmonized compendial standards for pharmaceutical ingredients and dosage forms. The concepts include development of standardized practices and enhanced collaboration among the pharmacopeias, as well as participation and agreement by the regulatory agencies.
BackgroundOne approach to achieving harmonized quality requirements for medicines is the creation of a single, global compendial standard. This was a key consideration in the recently published article describing the "ideal pharmacopeia" (1). But this idea is not new. The original objective in the creation of the International Pharmacopoeia (Ph. Int.) more than 60 years ago under the direction of the World Health Organization (WHO) was the creation of a unified pharmacopeia. The European Pharmacopoeia (Ph. Eur.), first elaborated in 1964, is a more recent example of the successful creation of a single, harmonized, broadly applicable pharmacopeia, where several individual national pharmacopeias previously existed. It is also recognized that the United States Pharmacopeia–National Formulary (USP–NF) and the British Pharmacopoeia (BP) provide compendial standards that are applied well beyond their geographical boundaries.
Other approaches to developing harmonized compendial standards include the efforts by the Pharmacopeial Discussion Group (PDG) and International Conference on Harmonization's (ICH) Q4B guideline (2). These activities, which generally focus on retrospective harmonization of widely used general chapters and excipient monographs in the USP–NF, Ph. Eur., and Japanese Pharmacopoeia (JP), have achieved some success, but are limited in scope and are time-consuming. It is well understood that there are inherent challenges in retrospective harmonization. More recent approaches include the prospective harmonization pilot project, a collaboration between the pharmaceutical industry, Ph. Eur., and USP to achieve harmonized API monographs (3).
Although these approaches have provided some progress toward creating harmonized compendial standards, they have largely been limited in their breadth and depth. In consideration of today's continuing reality of multiple national and regional pharmacopeias, and our need to serve a global patient population, other approaches must be considered to achieve a 21st century solution.