CFDA optimizes the supervision of pharmaceutical excipients


After four years of retreat, China’s regulation of the […]

After four years of retreat, China’s regulation of the gelatin market is becoming more standardized.

The State Food and Drug Administration recently organized the drafting of the "Requirements for the Examination and Approval of the Relevant Examination and Approval of Pharmaceutical Packaging Materials and Pharmaceutical Excipients (Draft for Comment)", and changed the packaging materials and containers and pharmaceutical excipients directly contacting the drugs from individual approval to approval. The drug registration application will be reviewed and approved together.

This change in policy will allow pharmaceutical companies to switch from just considering production costs to comprehensively examining the comprehensive qualifications of raw and auxiliary suppliers when selecting raw and auxiliary materials. Tian Hao, chairman of the International Branch of the International Pharmaceutical Excipients Association (IPEC China), said that the requirements for the supplier of excipients in the related review may indeed be improved, which is combined with the improvement of the management system of excipient suppliers in its own quality management system.

Although the "Draft for Comment" has not yet been officially released, it is undeniable that the entire capsule industry will face reshuffle again, and Cao Shenghui, general manager of the domestic well-known accessories company Lifan Capsule, believes that the future concentration of Top10 in the capsule industry is expected to reach More than 85%.

Industry upgrades Eliminate backward production capacity

After the outbreak of the "poison capsule" incident, the production and use standards of pharmaceutical excipients in China have been increasing year by year.

In April 2012, CCTV's "Weekly Quality Report" broadcasted the "Secret in Capsules". Some enterprises in Hebei used leather waste to form industrial gelatin and made medicinal capsules. However, the test results were often the total metal exceeded the standard. Once the original Ministry of Health and public relations organs were alarmed.

The regulatory authorities immediately issued a number of regulatory policies to quickly standardize industry standards. The introduction of the "Draft for Comment" not only strictly controls the quality of the products, but more importantly, shortens the administrative approval process and saves the production costs of the enterprise. Cao Shenghui believes that this move is a change in regulatory thinking.

According to the editor of 39 Health Net, the FDA has separately separated the approval of drugs and excipients. The procurement of excipients from pharmaceutical companies only depends on the approval of the General Administration. In the event of an accident, the responsibility is transferred to the excipients or the FDA.

However, if the relevant approval is implemented, the future means that the drug approval will include the approval of the auxiliary materials. This means that in the future, pharmaceutical companies have the responsibility to supervise the excipients and ensure that there are no problems in each batch. In the past, the phenomenon of low prices in the country will be curbed.

"After this measure was launched, the company's regulatory responsibility was clarified. After all, the use of the auxiliary materials, the people of the pharmaceutical enterprises are more aware of the risks. If the original responsibility can be clearly defined, the original poison capsule incident will not occur." Cao Shenghui It is believed that the related review seems simple, but will further increase the concentration of the entire auxiliary industry.

At present, the concentration of TOP5 in the capsule industry is estimated to have exceeded 50%, and several leading companies have expanded their production scale. In mid-November 2015, Lifan Capsule invested more than 60 million yuan to build a high-end capsule workshop with an annual output of 4 billion pieces. The production capacity of Lifan Capsule is expected to expand to 40 billion by the end of 2017.

Cao Shenghui believes that the auxiliary materials industry will usher in good development in the future: on the one hand, the demand for high-quality products by consumers is very obvious; on the other hand, the national drug regulatory management department is promoting product quality management and standards from all levels. With the implementation of these policies, the capsule industry is expected to usher in a new round of reshuffle.

Transparent regulation, the industry calls for the DMF system

With the upcoming official release of the related review system, the industry also called for the introduction of a DMF policy.

DMF (Registration of Pharmaceutical Raw and Auxiliary Materials) is a management model that is prevalent in developed countries and regions such as the United States and the European Union to strengthen drug production, quality and supervision. In the interview, both experts and enterprises have called for the DMF system to be formulated, improved and linked as soon as possible, and the related review and linkage with the DMF.

Professor Song Minxian, director of the National Pharmaceutical Technology Market Association's Pharmaceutical Excipient Technology Promotion Committee, believes that pharmaceutical companies have become increasingly demanding pharmaceutical excipients in recent years. The DMF system will require excipients to do more technical services and familiarize themselves with customer needs. .

The essence of the DMF system is to regard the source relief of the production of the preparation as a whole, and extend the regulatory reach to the entire quality chain of pharmaceutical production, so that the preparation manufacturer not only cares about its internal quality, but also knows more about the production process of its auxiliary materials. .

Cao Shenghui believes that the implementation of DMF is not only conducive to the review and approval of preparations, but also strengthens the supervision of medicines from the initial materials, guarantees the quality and safety of medicines from the source, and ultimately can promote the journey of production enterprises to become the main body of quality responsibility.

Driven by the new medical reform, China's pharmaceutical industry has shown rapid development, and raw and auxiliary materials and packaging materials manufacturers have sprung up. However, the production quality of multi-, small and scattered medicinal raw materials manufacturers is uneven. The demand for growth of pharmaceuticals driven by universal health insurance has made drug safety and quality assurance more prominent. As more domestic raw and auxiliary materials go to the international market, the quality response problem of international users has also become the focus, and it is extremely urgent to comprehensively improve the supervision level of raw materials production quality.

“The development of excipients must start from the level of improvement of the quality of the whole drug.” Cao Shenghui said that in the future, excipients should continuously improve the quality and technology of excipients, and at the same time reduce the cost through the improvement of the industrial chain, and also need to connect with the international market. Develop new and more efficient new products. On the other hand, in order to cooperate with the implementation of the related review and the DMF system, relevant enterprises need to pay close attention to the policy dynamics, prepare materials according to the DMF data declaration requirements, and welcome the information review and audit of the preparation enterprises and competent authorities.