CDE: Notice on Trial Submission of Electronic Application Data for Drug Registration by Network Transmission

Durst DST Regulation Group, noting that on July 1, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE) issued a trial notice on the submission of electronic application materials for drug registration by network transmission. Starting from July 1, 2024, the trial work on the network transmission of electronic application materials for drug registration will be started, and applicants can submit electronic application materials for drug registration through network transmission. There is also an attachment: the reservation for network transmission of electronic declaration materials and the description of operation steps, which is convenient to guide everyone to submit electronic declaration materials.

2024-07-05

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.

2024-07-05

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.

2024-07-05

Argument! Hengrui Warning Letter, Is It FDA's Political Sanction?

Tieguai Liu saw many posts about whether there were political factors in Hengrui's warning letter. Today, Tieguai Liu will discuss this matter with everyone's concerns. First of all, we are very sensitive to see that the "first brother" of China's pharmaceutical industry has received a warning letter from the FDA of the United States. For today's Sino-US environment, we naturally think of the FDA's sanctions against the first brother due to the influence of US politics. It is completely understandable from everyone's interpretation. The following Tieguai Liu will discuss with you from both positive and negative dimensions:

2024-10-25

Please collect the sea enterprises! Names and Websites of National and Regional Food and Drug Administration in Southeast Asia (Encyclopedia)

Durst DST continues to pay attention to the drug regulatory policies of countries around the world to help companies go to sea, and the following is the drug regulatory situation in Southeast Asian countries and regions.

2024-10-25

Application of Risk Management in Cleaning Verification

Risk management is a reasonable method to achieve good decision-making, which runs through the whole quality system management, GMP put forward the concept of quality risk management, clear enterprises in the whole cycle of drug production risk assessment. Then, risk management tools are also required for cleaning verification at the source of production, and below the scientifically set allowable residue level, the removal of production product residues or cleaning agent residues from equipment based on risk management methods is an integral part of cleaning verification.

2024-10-25

Have you written the quality manual of pharmaceutical enterprises?

In an audit of the quality management system documents of pharmaceutical companies, the consultant DST found that there were some problems in the development of quality manuals for pharmaceutical companies:

2024-10-25

Supplier audit, colleagues need not worry, have reference

Supplier Management As part of the daily work of QA, materials are subject to strict qualification and on-site review before they are identified as qualified suppliers. As required by China GMP(2010 Edition), Chapter 10 (Quality Control and Quality Assurance), Section 7 (Evaluation and Approval of Suppliers) and Appendix (Computerized Systems):

2024-10-25

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.

2024-10-25

Congratulations! Durst and Chongqing Zhixiang Jintai Biology Successfully Held EU GMP QP Project Launch Meeting

Recently, the team of experts from Dust went to Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. and successfully launched the "Chongqing Zhixiang Jintai Bio-EU GMP QP Project" kick-off meeting.

2024-10-25