"Public hospital reform, clinical trial self-examination, medical anti-corruption, tiered diagnosis and treatment, centralized drug procurement, consistency evaluation, the most stringent anti-resistance, two-invoice system and other policies have caused a storm of anti-corruption in the medical industry. According to reports, the national The directors and secretaries of at least 155 hospitals have been investigated. . . "
The pharmaceutical industry is an important field closely related to people's life and health, and the compliance of the pharmaceutical industry is the cornerstone of ensuring the healthy development of the industry. At present, my country's pharmaceutical industry is in an important historical stage of leapfrogging from high-speed growth to high-quality development. Under the new normal of strong supervision and strict supervision, compliance operation, transformation and upgrading are important measures to promote high-quality development and promote the transformation of the pharmaceutical industry from large to strong.
This article will discuss the importance of compliance in the pharmaceutical industry and how to establish and maintain a compliance mechanism to provide a reliable guarantee for the sustainable development of the industry.
1. The importance of compliance
The compliance of the pharmaceutical industry is the cornerstone of ensuring the healthy development of the industry. It can ensure the fair competition of pharmaceutical companies, protect the rights and interests of consumers, maintain the image of the industry, and help prevent and reduce the occurrence of violations of laws and regulations. In particular, the pharmaceutical industry is highly specialized, has a long industrial chain, has many participants, and involves a wide range of areas. There are high compliance risks in terms of product promotion, finance and taxation, unfair competition, monopoly, information security, etc. Under the background of heavy national governance, the entire pharmaceutical industry should be deeply aware of the urgency of compliance.
2. Establish and maintain a compliance mechanism
1. Internal rules and regulations: Pharmaceutical companies should formulate a series of internal rules and regulations to clearly stipulate the laws, regulations and industry norms that employees should follow in various business activities. The system should include compliance requirements for all links from research and development, production to sales, so as to ensure that the enterprise complies with relevant regulations in all aspects.
2. Training and education: Conduct regular compliance training to enable employees to understand the laws, regulations and industry norms of the pharmaceutical industry and enhance compliance awareness. The training content may include knowledge dissemination, case analysis, etc., to help employees identify compliance issues and deal with them.
3. Supervision and inspection and self-examination: Establish a compliance supervision and inspection mechanism to strengthen the supervision and control of all links. At the same time, pharmaceutical companies should carry out regular self-examinations to discover and resolve compliance issues to ensure that their operations comply with regulatory requirements.
4. Compliance risk assessment: conduct regular compliance risk assessments, analyze the compliance risks that pharmaceutical companies may face in their business operations, and take corresponding preventive and management measures to minimize the occurrence of risks.
5. Strengthen the construction of a digital compliance system: The compliance of pharmaceutical companies does not generally require companies to "operate in accordance with laws and regulations", but requires companies to establish a set of systems aimed at preventing, identifying and responding to possible violations of laws and regulations. Self-regulatory mechanisms.
At present, the two products of Tianjin Daoben Technology Co. , Ltd., the "compliance number" product and the "smart compliance" management platform, can meet the different needs of pharmaceutical companies. The "Compliance Number" product can not only help companies "check the law with facts", but also provide pharmaceutical companies with a compliance list in the pharmaceutical industry , helping pharmaceutical companies to conduct compliance self- examination in real time. The "smart compliance" management platform can also strengthen and improve the governance system of pharmaceutical companies, promote the construction of a long-term compliance management mechanism, improve the risk management system and mechanism, continuously improve the level of internal control compliance, and continuously consolidate the foundation of compliance operations .
