Frontier Service Optimization Process | Dalian Pharmaceutical Import Clearance Speeds Up
The medical website reported on June 12 that after optimizing the drug approval process, not only can it be put into production more than 20 days in advance, but this year it can also save the company 520,000 yuan in airport storage costs. ' Pfizer Pharmaceuticals Co., Ltd. Dalian Plant (hereinafter referred to as 'Pfizer Dalian') Yu Qingli, the import and export manager, said with joy.
Pfizer Dalian is an AEO (certified operator) company certified by the customs department. In 2017, the company's annual production value reached 19.7 billion yuan, and its application for import drug The volume of customs clearance accounts for more than 60% of the total customs clearance orders of the Dalian Port Drug Administration. In recent years, the company has imported raw material medicines and semi-finished products annually at a rate of 20% to 30%.
On April 26, the State Drug Administration issued an announcement on matters relating to the inspection of imported chemical products for customs clearance. It was clarified that imported chemical raw material medicines and preparations (excluding chemical products sold for the first time in China) were no longer mandatory for batch inspections at the time of import. At the same time, the Liaoning Provincial Government also initiated a special rectification work on the “difficulties in handling affairs”. On April 28, the Food and Drug Administration of Liaoning Province issued 15 resolutions. enterprise (The masses) 'Difficulties in handling' measures.
'We actively explore and innovate in accordance with the work requirements of the State Drug Administration and the Liaoning Food and Drug Administration. We take the initiative to rely on our previous services and do our utmost to open convenient channels for enterprises to help enterprises solve their problems.' Dalian Food and Drug Administration Bureau Administrative Approval Department Director Wang Shuqing said.
For the speed of drug clearance, food and drug regulatory authorities and businesses are working hard.
On May 3rd, Pfizer Dalian submitted a customs clearance application for the raw material drug 'Amlodipine besylate' imported from the United States. In only half an hour, it received a customs clearance form for imported drugs.
In accordance with the "Administrative Measures on Imported Drugs," the certificate of origin of imported drugs is one of the main requirements for the filing of customs clearance. However, most of the origin certificates imported by Pfizer Dalian are only after the goods have left Hong Kong. Chamber of Commerce officially issued, arrival time lags behind the time of arrival of the goods 3 to 5 days.
'We mostly import medicines from the United States, Europe, and Singapore. We require storage and transportation throughout the entire 2°C to 8°C or 15°C to 25°C environment. Therefore, the storage conditions at the airport are more stringent. Once the airport warehouse locations are not Open, the risk of drug quality will increase. ' Yu Qingli said. Dalian Food and Drug Administration understand the situation, organize relevant business departments to conduct research, and finally determine the 'corporate commitment + department supervision' approach to help companies quickly handle drug clearance.
Under the premise of not checking the originals, Dalian Food and Drug Administration required the company to make a written commitment to ensure the authenticity and validity of the certificate of origin of the originating certificate. A customs clearance audit was conducted and the supervisory authority reviewed the original certificate of origin in the daily supervision. 'Wang Shuqing explained that 'before it was necessary to see the original certificate of origin in order to be audited. 'Pfizer Dalian imported raw materials from the United States' benzene sulfonic acid ammonia Chloridepine', which means that after the company got a fax, it passed a written commitment to get a customs clearance slip while the goods arrived at the airport.
It is understood that as of now, Dalian City has optimized the approval of 21 tickets for customs clearance of imported drugs.
In addition to helping companies speed up customs clearance, Dalian Food and Drug Administration also implemented an audit system to reduce the number of corporate material filings.
It is reported that Pfizer Dalian has "imports issued by the drug regulatory authorities of 20 countries. Drug Registration "Certificate," more than 230 submissions of customs clearances for imported drugs are required each year, and the number of submissions has increased year by year.
In order to reduce the burden on enterprises, Dalian Food and Drug Administration has adopted a “one-off audit” approach to conduct one-time verification of the original “imported drug registration certificate” of the company and retain a copy, which is valid in the “imported drug registration certificate”. Under the premise of no change, the enterprise can provide the original one time.
Yu Qingli believes that the Dalian Food and Drug Administration's optimization of the drug approval process is to optimize the business environment, greatly shorten the logistics time for imported drugs, reduce the logistics cost of the enterprise, and at the same time reduce the quality of imported drug port storage. Risk. 'Optimize the drug approval process, for the company is - good! Good! Good!' Yu Qingli even claimed praise.
