Striving for excellence in China	January 2009

By Chris Perkin, corporate senior VP and president of Canadian Preclinical Services, Charles River

During the Summer Olympics in August, international attention was fixed on China as athletes from across the globe strived to achieve excellence in their sports. Contract research organizations in China also know about striving for excellence, as they work to provide good laboratory practice research and drug-development support in this emerging market. As more multinational pharmaceutical companies make forays into China, CROs must have a presence there to support the growing demand from multinational pharmaceutical clients for outsourced drug development services. By ensuring regulation conformity, supply chain integrity, and quality and compliance maintenance, CROs can have a role in helping their China facilities achieve excellence in drug discovery and development. Ensuring that Chinese sites provide the globally recognized high standards of research, safety, humane care and good laboratory practices will play a key role in the region’s success. In addition, CROs must make key strategic investments in local resources and staff to support the development of local facilities.

With its impressive pool of native scientific talent, large population with unique therapeutic needs, rapidly growing economy, and rising interest in Western products and services, China is emerging as a powerhouse in the life sciences industry. According to Status Quo of Drug Supervision in China, a white paper published by China’s State Council, China has about 20,000 medical enterprises producing 1,500 types of drugs, 1 billion doses of vaccine per year, and 3,000 types of medical devices. The white paper also highlights the country’s total pharmaceutical output rate. This value rose from $20 billion in 1998 to around $100 billion last year. China’s pharmaceutical exports rose from $3.4 billion in 1998 to $24.6 billion in 2007. As a result, China is primed for an influx of CROs to support this burgeoning industry. Just like Olympic athletes, CROs have to overcome barriers to achieve excellence in this new market. 

Notably, China’s reputation as an exporter has suffered in the past few years from tainted products in a variety of industries, including the pharmaceutical industry. Earlier this year, a shipment of heparin imported from China was found to be contaminated, costing the lives of many of those it was intended to save.  As a result, government, business, and consumer trust has eroded for many pharmaceuticals produced in the country. This is a special obstacle related to China, but for CROs looking to establish complex business operations overseas in a new culture, there are many impediments to overcome. The three biggest hurdles are meeting complicated, tightening international regulatory requirements; establishing trustworthy supplier relationships; and maintaining continuous quality control.

Meeting international standards
Navigating the labyrinth of domestic regulatory requirements for research, safety, and humane animal care in a domestic setting can be a daunting task, and meeting these regulations in an international location can seem like an insurmountable task.
But any CRO that plans to have a successful presence in China needs to stringently meet Western standards as well as Chinese national standards. The CRO should provide a wide range of services that are compliant with leading regulatory agencies including Association for Assessment and Accreditation of Laboratory Animal Care; Canadian Council on Animal Care; China’s State Food and Drug Administration; Organization for Economic Cooperation and Development; and U.S. Food and Drug Administration.

As China continues to evolve as a center of innovation in research and development, providing good laboratory practice-compliant preclinical services is critical to fostering this culture as well as helping academia, scientific societies, and multinational and native biopharmaceutical organizations accelerate their drug development programs. To ensure a new facility meets global standards of research, safety, and humane animal care, CROs need to access their pool of expert, Western facility staff members. These individuals know how to apply facility design standards and can oversee the construction of a China facility. These expert staff members would manage a team comprising specially selected scientists, technicians, regulatory and compliance personnel, engineers, architects, and validation experts from China and North America to oversee the construction and building commissioning processes.

This international collaboration is vital to success. Although many Western experts have immense experience in the design of facilities to global regulatory standards, local experts who are well-versed in the intricacies of China’s building and regulatory environment are needed to anticipate and plan for site permit and pre-operation inspections. When a company is attempting to establish an overseas presence in this type of regulated industry, multiple levels of regulation are involved. As a result, a CRO needs to have a wide spectrum of global and local experts on hand. In addition, validation plans need to be incorporated into the larger project plan and reviewed by a trained quality assurance team to make sure they meet industry, United States and China, and corporate standards.

Establishing vendor/supplier relationships
Developing key local or regional vendor supplier relationships is imperative when establishing any kind of business overseas. The customary and trusted vendors may not have the reach, knowledge, or resources to meet specific needs in another country or the level of quality desired. Vendors and suppliers must understand the lay of the land and have the ability to provide the quality materials and services to a CRO client. To establish this network of preferred vendors and suppliers, a parallel approach should be used, including a short-term set and a long-term set of plans. For the short term, decide what needs to be imported at first to ensure compliance with international standards.  Importation can be costly, but the benefits in the short term are that the quality is already validated. 

While the short-term plans are under way, CROs should plan for the future by locating and vetting local suppliers who meet international standards.  In some cases, a CRO will have to establish relationships to help the local vendors produce a product that meets the required standards. In the end, this approach will reduce supply costs while still maintaining rigorous quality standards.

Achieving continuous quality and compliance
Once the foundation has been laid for quality and global regulatory compliance for a China facility, the problem becomes one of sustaining those goals. With experienced leadership, staff training programs, and quality control mechanisms in place, a CRO can establish a culture of quality assurance and good laboratory practice compliance at the new facility. With continuous monitoring and ongoing training programs, this culture of quality assurance will eventually start to become autonomous.  Quality and regulatory compliance, at the most basic level, are ways of thinking and acting.  Eventually, they become the natural way that people think and act.

Continuous monitoring for quality and compliance, although an ever-present task, is something that must be planned in advance. This is accomplished by hiring expert management, setting up appropriate training programs for facility staff, and instituting quality assurance groups that will validate every stage of the drug discovery and development support process. CROs should make use of their domestic resources and import director – and other high-level staff from other global locations – to oversee the China facility and help train employees, including study directors, chemists, pathologists, quality assurance auditors, and technical and operations group members. Team members should receive training at domestic facilities before being transferred to China, as well as continuous training to ensure best practices.

Making a strategic investment in local resources and staff to support drug-development programs is critical to sustaining quality and compliance. A necessary component of this investment is the transfer of expertise and Western lessons learned to Chinese talent, including high standards of research, safety, humane care, and good laboratory practices. The goal is not to have a Chinese facility that is staffed and operated from the West, but to create an autonomous operation that meets the same regulatory and quality standards as its Western counterparts. CROs should also establish an expert quality assurance unit to guarantee the integrity of the facility and its products and services. The unit’s ongoing task will be to ensure that industry and government expectations are achieved or exceeded.