Pharmaceutical Company Accepts Special Inspection on Pharmacovigilance
Release time:
2020-08-17
Pharmaceutical Company Accepts Special Pharmacovigilance Inspection
News 7# On the morning of May 9 , relevant leaders of Zhejiang Adverse Drug Reaction Monitoring Center went to Jianfeng Pharmaceutical Company to carry out pharmacovigilance research exchange and special inspection. The
inspection team conducted a detailed inspection of the personnel, institutions, individual adverse reactions and group adverse events of the pharmaceutical company, and fully affirmed the pharmacovigilance work of the pharmaceutical company. At the same time, it is hoped that the pharmaceutical company can creatively carry out the pharmacovigilance work on the basis of checking and filling the vacancy. The relevant person in charge ofPharmaceutical Company said that he would continue to implement the main responsibility of the holder, do a good job in the management of the whole life cycle of drugs, and effectively ensure that the people use "
rest assured medicine " .
78 , the pharmaceutical company sent personnel to attend the 2020 Jinhua pharmacovigilance and risk warning seminar. during the meeting, drug marketing license holders made speeches on the difficulties and doubts in their respective work, and Lu Xiaoqin, chief of the monitoring department of Zhejiang provincial center, gave one-on-one doubts and guidance. (Fan Fangwei)
Related Links:What is Pharmacovigilance?
Pharmacovigilance is scientific research and activities related to the detection, evaluation, understanding and prevention of adverse reactions or any other problems that may be related to drugs. Pharmacovigilance involves not only adverse drug reactions, but also other drug-related problems, such as substandard drugs, drug treatment errors, lack of effectiveness reports, medication for indications that are not recognized without sufficient scientific basis, case reports of acute and chronic poisoning, evaluation of drug-related mortality, drug abuse and misuse, adverse interactions between drugs and chemical drugs, other drugs and food.
Pharmacovigilance starts from the safety of the user to discover, evaluate and prevent adverse drug reactions. Require doubts to report, regardless of the quality of drugs, usage, dosage is normal or not, more attention to comprehensive analysis method to explore the causal relationship, easy to be accepted by the majority of reporters. The main contents of pharmacovigilance include: early detection of adverse reactions of unknown drugs and their interactions; discovery of the growth trend of adverse reactions of known drugs; analysis of risk factors and possible mechanisms of adverse drug reactions; quantitative analysis of risk/
benefit evaluation, release of relevant information, promotion of drug supervision and management and guidance of clinical drug use.
The purpose of pharmacovigilance includes: evaluating the benefits, harms, effectiveness and risks of drugs to promote their safe, reasonable and effective application; preventing safety issues related to medication, improving patient safety in medication, treatment and auxiliary medical care; Educating and informing patients about drug-related safety issues, and improving public health and safety related to medication.The ultimate goal of pharmacovigilance is the rational and safe use of drugs; risk/
benefit evaluation and communication of marketed drugs; training, education, and timely feedback of relevant information to patients.
More information
Publicity of Environmental Protection Acceptance for Completion of Kiln End Flue Gas Desulfurization Project of daye peak cement co., ltd. According to the requirements of the Interim Measures for Environmental Protection Acceptance for Completion of Construction Projects (No.4 [2017] of the State Environmental Regulations) issued by the Ministry of Environmental Protection, the environmental protection acceptance information of "Kiln End Flue Gas Desulfurization Project" of daye peak cement co., ltd. is now publicized. Basic Information of 1. Project Project Name: Kiln End Flue Gas Desulfurization Project Construction Unit: daye Jianfeng Cement Co., Ltd. Project Construction Location: Yongguang Village, Baoan Town, daye city, nature of the project in the existing plant area of daye Jianfeng Cement Co., Ltd.: The construction content of the technological transformation project is: This technological transformation project is mainly to build a wet desulfurization system for kiln end gas of the company's existing 4000t cement clinker production line, adopting limestone-gypsum wet flue gas desulfurization process. The project covers a total area of 500 m2, with a new construction area of about 450 m2. It mainly builds desulfurization complex building, flue gas system, SO2 absorption system, limestone powder conveying and limestone slurry preparation system, process water system, gypsum dehydration system and supporting pipelines. Power supply, water supply, compressed air and other public works rely on the existing plant. Total investment and environmental protection investment: the total investment of the project is 10.37 million yuan, all of which are environmental protection investment. The project was entrusted to Huangshi Yangtze River Environmental Engineering Design and Research Institute to carry out environmental impact assessment in September 2017. On November 16, 2017, Daye Municipal Environmental Protection Bureau issued a reply with YEHAN [2017] No. 354. Implementation of 2. environmental protection measures The scope of this acceptance is the flue gas desulfurization system and supporting facilities at the end of the kiln. (1) Exhaust gas pollution
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
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