How to widen the paths for the International Development of Chinese Formulation Companies
Tuesday, 16 July 2019｜Source：CHINA CHAMBER OF COMMERCEFOR IMPORT&EXPORT OF MEDICINES &HEALTH PRODUCTS｜Author：
In recent years, the export of formulations has become one of the important signs of Chinese pharmaceutical companies going global. In 2018, China's formulation exports to developed markets grew 38.39% to US$2.372 billion, among which, the exports to regulated markets of the Europe, the U.S. and Japan increased significantly, and maintained a steady growth momentum, indicating the accelerating pace of going out of Chinese formulations.
According to insiders, the competition in the pharmaceutical industry is intensifying, and the concentration of capacity is constantly improving. Many formulation companies focus on the future development trend of the industry and gradually go global. For instance, the pharmaceutical R&D No. 1 player, Heng Rui Medicine has its own going out strategies by focusing on the ?elds with complex processes and high technological requirements such as injections, as well as fields with large market capacity such as anti-tumor formulations and surgical anesthetics.
Advantages of APIs and formulations
As the formulation industry grows, many pharmaceutical companies have carried out international projects by taking advantages of their API and formulation technology superiorities, and will complete the submission of generic drug registration applications to FDA and NMPA at the same time, aiming to realize the sales of products in the U.S. and Chinese markets simultaneously.
Pharmaceutical companies will also accelerate their transformation and upgrading and the pace of international development by adhering to innovation-driven development, and shifting from ordinary generic drugs to new dosage forms of generic drugs, innovative drugs, biopharmaceuticals and other ?elds. Meanwhile, the international development of formulations will be integrated into the construction of the “Belt and Road” to achieve a global layout.
The Guidelines for the Development of Pharmaceutical Industry for the 13th Five-Year Plan Period proposes to implement the international development goal of Chinese formulations, comprehensively increase the scale and market share of formulation exports and the added value of Chinese formulations, and focus on expanding the developed and emerging pharmaceutical markets. Policy support has also greatly promoted the going out pace of Chinese pharmaceutical companies. Data shows that the international development of Chinese formulation companies was fruitful in 2017. ANDA approvals obtained by local enterprises reached a record 38, indicating that Chinese pharmaceutical companies are full of momentum.
Profit-earning capacity needs to be improved
However, the international development of Chinese pharmaceutical companies is still in its infancy, and the overall level is still weak. Insiders pointed out that the formulation industry faces the challenges of excessive homogenization competition and serious imbalance between input and output caused by weak overall competitiveness, lack of international thinking and concepts, overcapacity and unreasonable redundant construction. The profitability of China's exported pharmaceuticals needs to be improved.
Speci?cally, on the one hand, Chinese pharmaceutical companies face obstacles of cultural and ideological con?icts in their process of international development. In recent years, although the reform of the supervision system has accelerated, the long-term conservative regulatory model has led to the gaps in aspects of product approval, standard management, inspection and testing, etc., which have not yet been fully integrated with the international standards.
Therefore, formulation companies need to be acquainted with the international rules and standards, understand the international requirements relating to formulation registration, quality, production, etc., and accurately identify positions and focuses, so that the standards in all aspects of the products are consistent with the international standards.
On the other hand, Chinese formulation companies need to attach more importance to product quality improvement and process innovation, and increase superiorities and competitiveness to comply with increasingly stringent domestic and international regulatory requirements. At present, there are pharmaceutical companies that cooperate with foreign pharmaceutical companies to reduce the risks in the international production process of formulations, thereby improving the product qualities.
Generally, in the context of global competition, the international development of Chinese formulation companies needs to take the bilateral relationship and interests into account, constantly learn and comply with the international standards and rules, and continue to improve the quality and technology level of formulation products. All these contribute to the international development of Chinese formulation companies.
The industrial structure adjustment of Chinese pharmaceutical industry has been accelerated, pharmaceutical management and regulation have been further integrated with the international standards, and the going out pace of Chinese pharmaceutical companies has accelerated. In such a context, relying on the overwhelming brand appeal of CPhI China, exhibitors can receive high attention from API, excipient and formulation companies, and pharmaceutical regulatory agencies and pharmacopoeia institutions from di?erent companies will be invited to help companies gain a deeper understanding of the regulatory requirements and market access requirements of various countries. As the brand conference of the CPhI China, experts will share the latest information about pharmaceutical regulatory policies and laws to help companies improve the construction of product registration and quality systems, and further improve their abilities to enter the mainstream markets and emerging markets. CPhI China 2019 is not only a high-end, open and shared platform for the exchange of pharmaceutical regulations between the domestic and international pharmaceutical industries, but also an important window for Chinese pharmaceutical industry to be in line with international standards.
Source：CCCMHPIE