The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/216720
Regulatory Compliance/FDA Emerging Markets And Your Global Regulatory Strategy By Suzanne Elvidge, contributing editor I n the early 1980s, talking about the worldwide pharmaceutical market really meant the U.S., Japan, and Europe, which comprised the bulk of total sales, with the rest of the world (ROW) thrown in somewhat as an afterthought. Today, ROW is a term of the past, and with increasing speed, the concepts have changed from "developing" to "emerging" and now to "growth" markets, with China already today having become a major market, the number two global pharmaceutical market. THE SIZE, SIGNIFICANCE OF ASIA AND THE EMERGING MARKETS Asia has a population of around 4.3 billion and is home to about 60 percent of the world's population. China alone has a population of approximately 1.3 billion, which is three- to fourfold bigger than Europe or the U.S. Adding in the other developing markets, such as those in Latin America, this makes for a huge potential market for the pharmaceutical industry, and one important not to miss. It's more than just taking advantage of a growing market, however, as Joseph Scheeren, senior VP, head of global regulatory affairs and site head of global development Beijing at Bayer HealthCare, explains. "We started positioning ourselves in this market early on. While we are number 14 in the top20 list of pharmaceutical companies worldwide, we are number 4 in China. It's not just about looking for growth, but also providing access to drugs for patients in these regions on humanitarian grounds, in line with our company mission, 'Science for a better life.'" The growth markets include Brazil, 40 LifeScienceLeader.com Russia, India, China, Mexico, South Korea, and Turkey, also known as the BRIC-MST countries. The environment is changing rapidly, however, and the focus is now on China, Brazil, and Russia. "The GDP is rising in these countries, and generally, as the GDP increases, healthcare expenditure also increases," says Scheeren. "For example, in China, the government is investing heavily in healthcare. It's always important to keep an eye to the future for breakthrough areas, and the next markets to watch are likely to include Taiwan, Indonesia, the Philippines, and Vietnam — these regions combine a large population and a growing GDP." CREATING AND ALIGNING THE REGULATORY STRATEGY Pharmaceutical companies such as Bayer have a global footprint and strive for simultaneous global launches at the earliest time, including in growing markets. Aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients. "Once a drug reaches Phase 1, it's a good idea to start discussions with global regulatory authorities so that you can begin to create the worldwide development program. The aim is to achieve a single global clinical plan that includes the major markets — the United States, Europe, Japan, December 2013 and China. This global plan will face challenges from individual market environments and regulatory requirements that can lead to having a separate development for some countries. Once all data is available, and the regulatory dossier has been finalized, we try to submit it simultaneously globally," says Scheeren. He goes on to explain that creating this strategy is dependent on the different regulatory requirements in the markets. For example, simultaneous submission is usually not feasible in China, where a CPP (certificate of pharmaceutical product) and approval in one of the major markets are typically first required. The basic dossier for Europe and the United States, however, can be adapted to local requirements in the other markets, and the submission requirements overall are gradually harmonizing under the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) process. "When the ICH process began, in the 1990s, harmonization started with Europe, the United States, and Japan. Many other countries have now followed suit, and the trend is toward global harmonization," says Scheeren. "As a general rule in growth countries, the Latin American markets tend to be the most homogenous,