In recent years, with the rapid development of China's economy and the continuous improvement of the living standards of domestic residents, the demand for imported pharmaceutical products in the domestic pharmaceutical market is also expanding and the requirements are getting higher and higher, which promotes Chinese medicines to some extent. Regulators continue to strengthen supervision of imported pharmaceutical products.
With the entry into force and implementation of China's 2010 version of the Good Manufacturing Practice (hereinafter referred to as GMP), the State Food and Drug Administration (CFDA) has started overseas GMP audits. Since 2011, dozens of overseas pharmaceutical manufacturers exporting pharmaceutical products to China have received CGMP audits of their overseas factories. With the development of CFDA's overseas audit work, both the level of auditing and the intensity of auditing have been continuously strengthened, and the scale of auditing has also shown an upward trend year by year.
After five years of hard work, the number of foreign drug manufacturers that have undergone CFDA overseas audits has grown from scratch, from the initial number of companies in the first year to nearly 100 companies each year, and continues to increase. The past era of exporting pharmaceutical products to China simply by submitting registration information to CFDA without going through GMP audits is over.
From the results of the CFDA's inspection of overseas pharmaceutical manufacturers in the past five years, the key issues that overseas pharmaceutical manufacturers are more likely to overlook are the following:
1. China's drug-related regulations are updated at a faster rate. Overseas companies have not paid attention to the update of China's drug-related regulations in a timely manner, and have not organized production according to China's latest drug-related regulations;
2. The registration data submitted to CFDA is not consistent with its overseas production status and the latest product information, and the relevant contents of the registration materials are not updated according to the actual situation of the production site and the latest standards of the products;
3. The production site does not meet the requirements of China's 2010 edition of GMP and its related regulations or there is a deviation in understanding and implementation;
Because CFDA's overseas audit work has not been carried out for a long time, many foreign pharmaceutical manufacturers still have many questions about CFDA's overseas audit, and the representative ones are as follows:
1. Check the characteristics and style;
2. The specific procedures for the inspection;
3. The regulatory basis for the inspection;
4. The extent and intensity of the inspection;
5. Focus of attention;
6. Determination of inspection results
In view of the fact that overseas drug exporters are ignorant or little aware of the overseas audit of Chinese drug regulatory agencies, Kanglihua has recently established its traditional advantages based on the experience and success stories of overseas GMP consulting services provided in recent years. GMP consultation, expanding to overseas, that is, through the field of GMP consulting related business, the consultants who have years of experience in GMP auditing and have good English communication skills are stationed at overseas drug manufacturers. Compared with Kanglihua's traditional domestic GMP consulting business, the overseas GMP consulting business has the following characteristics:
1. Specialized, combined with Kanglihua's rich GMP consulting experience and hundreds of successful cases, it can provide tailor-made GMP consulting services for overseas pharmaceutical manufacturers, which are highly reliable and non-replicable. For overseas pharmaceutical manufacturers to successfully escort through the audit of Chinese drug regulatory agencies;
2. Targeted, for the geographical characteristics, historical characteristics, cultural characteristics, product characteristics and special requirements of Chinese pharmaceutical regulatory agencies for a particular product, for overseas pharmaceutical manufacturers, to develop more targeted strategies for enterprises, Make overseas pharmaceutical manufacturers more in line with certain special requirements of China's drug regulatory authorities;
3. Compatibility, on the basis of ensuring the company's own quality system as much as possible, to make it more in line with the requirements of China's drug-related legal norms, so that the quality system of overseas pharmaceutical manufacturers under different drug regulatory systems is more compatible and Practicality
4. Integration, with the history of Conley's nearly 20 years and the brand influence of Conley, Conley will make full use of its two major traditional businesses, such as drug registration and GMP consultation, to provide pharmaceutical manufacturers with registrations from pharmaceuticals to GMP. Consulting a series of services to ensure that overseas pharmaceutical manufacturers can successfully pass the audit of Chinese drug regulatory agencies, minimizing the cost of the company itself and unnecessary key risks;
5. Platformization, as one of the largest CRO companies in China, a member of Tiger Pharmaceutical Group, Kanglihua can rely on the parent company Tiger Pharmaceutical Group to provide overseas pharmaceutical manufacturers with clinical trials, data collection and collation. Services to save valuable resources of overseas pharmaceutical manufacturers.
So far, Conoco has successfully signed overseas GMP consulting services with the world's leading blood products manufacturer, CSL Behring, Switzerland, and the world's leading natural medicine manufacturer, Bionorica, Germany. Agreement, and successfully provided training and GMP consultation services for China's 2010 GMP and related regulations for the German factory in Biologa, and received good results, and was recognized by the German factory in Oro Liga. .
In summary, in 2017, Conley will continue to provide quality GMP consulting services for Swiss Jetbelin and German Biologa and other overseas pharmaceutical manufacturers, including on-site simulation audit, on-site translation, on-site training, GMP site. Consulting and guidance, GMP audit planning and other customized and non-customized services, and ultimately through CFDA's overseas audit.
At present, Kanglihua's overseas GMP consulting services mainly focus on China's GMP consulting services, and also provide GMP consulting services in other major regulatory countries and regions, such as FDA, EMA/EDQM, TGA, etc. I hope that with our joint efforts and cooperation, CFDA's overseas audit is no longer mysterious.