media – Page 168 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What are the requirements of EU medical device CE audit for quality management system document control?

Drugdu.com expert’s response: The CE certification requirements for medical devices in the European Union (EU) are quite stringent in terms of quality management system (QMS) document control. Below is an overview of the specific requirements: I. Content and Requirements of QMS Documents Completeness: The QMS documents should include policies, procedures, guidelines, forms, records, etc., comprehensively covering all aspects of the quality management system. These documents need to detail and prove that the product complies with EU regulations and standards, including but not limited to product design descriptions, performance test reports, risk assessment reports, biocompatibility assessment reports, electromagnetic compatibility test reports, etc. Accuracy: The information in technical documents must be accurate and capable of truthfully reflecting the technical characteristics and safety performance of the product. Traceability: The QMS documents should ensure the traceability of product quality, including raw material sources, production processes, quality control, and other links. Continuous Improvement: The QMS ...
- Source: drugdu
- 372
- February 5, 2025
Tianyu Pharmaceutical’s Avatrombopag Maleate Bulk Drug Substance Passes CDE Review

On January 27, it was reported that Tianyu Pharmaceutical (300702) announced that its avatrombopag maleate bulk drug substance has recently passed the review of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This bulk drug substance belongs to chemical drug category 4, with the registration number Y20230000333, and the review result, jointly evaluated with the preparation, is A. The company submitted the registration application for avatrombopag maleate bulk drug substance to CDE in June 2023 and was accepted. Although this bulk drug substance has passed the CDE review, it still needs to obtain a “meeting requirements” result from the GMP compliance inspection by the Zhejiang Provincial Medical Products Administration before it can be launched and sold in China. Currently, 14 manufacturers in China have passed the CDE technical review. The company is preparing to apply for the GMP compliance inspection, and the time for market launch ...
- Source: drugdu
- 238
- February 4, 2025
Livzon Group’s Recombinant Human Follicle – Stimulating Hormone Accepted by the Drug Administration

On January 26, it was reported that Livzon Group (000513/01513) announced that the application for domestic drug production registration of the recombinant human follicle – stimulating hormone injection developed by its holding subsidiary, Zhuhai Livzon Mab Biotech Co., Ltd., has been accepted by the National Medical Products Administration. The specification of the accepted drug is 33μg (450IU)/0.75mL, and the registration category is 3.3 for therapeutic biological products. According to the announcement, the cumulative R & D cost of the recombinant human follicle – stimulating hormone injection has reached 104 million yuan. The announcement mentioned that the indications of the recombinant human follicle – stimulating hormone injection include anovulatory women, superovulation in assisted reproductive technology, and patients with severe luteinizing hormone and follicle – stimulating hormone deficiencies. The market demand for the drug has been continuously increasing due to the annual rise in the domestic infertility rate. In 2023, the domestic ...
- Source: drugdu
- 286
- February 4, 2025
Can Shanghai Prescribe Original – Research Drugs for Hypertension? Many Clinicians Reveal the True Situation of “Drug Shortage”

Recently, a piece of news that “Shanghai hospitals have received notice that original – research drugs for hypertension can be prescribed” has been spreading online. However, some patients who went to the hospital said, “We still can’t get imported drugs.” What exactly is going on? A reporter from Yicai Global interviewed many clinicians from top – tier hospitals and community hospitals in Shanghai. It was learned that there are more than a dozen imported original – research drugs for hypertension that can be prescribed in large hospitals. However, the mechanisms and curative effects of these drugs are not all the same. For some popular hypertension drugs, such as Pfizer’s amlodipine besylate tablets, the original – research drug “Norvasc”, there is indeed an imbalance between supply and demand. There may be a situation of “no drugs available” in general outpatient clinics. On January 24th, the reporter from Yicai Global learned from ...
- Source: drugdu
- 363
- February 4, 2025
The National Medical Products Administration Issued a Correction Statement! “Deeply Apologetic”

On January 24th, the Center for Drug Evaluation of the National Medical Products Administration released a correction statement, aiming at the problem of data duplication existing in individual varieties publicly disclosed on the website of the Center for Drug Evaluation of the National Medical Products Administration. After verification, it was due to editing errors when disclosing relevant product information in 2019 and 2021. The wrong information has been corrected on the center’s website as soon as possible. The details of the statement are as follows: Recently, the Center for Drug Evaluation of the National Medical Products Administration received reports from relevant media and enterprises that there were problems of data duplication in individual varieties publicly disclosed on the website of the Center for Drug Evaluation of the National Medical Products Administration. The Center for Drug Evaluation of the National Medical Products Administration immediately verified the data of relevant varieties. After ...
- Source: drugdu
- 356
- February 4, 2025
MEDBALTICA

Organiser：Latvian International Exhibition Company Time：September 25 – 26, 2025 Address：Kipsalas iela 8, Riga, Latvia Exhibition hall：Riga International Exhibition Centre Product range: Medical Equipment: Medical devices and machinery, laboratory equipment/technology, diagnostic equipment, pharmaceuticals, surgical instruments, orthopedics and rehabilitation, dental materials and services, optics and ophthalmology, biotechnology, medical services, hospitals, insurance. Healthcare: Maternal and child healthcare, nutrition for children, homeopathic remedies, food supplements, modern information technology in healthcare. Raw Materials: Raw materials and ingredients for pharmaceutical production, equipment for medical institutions, ambulances and rescue services, health and beauty products, medical clothing, pharmaceutical packaging. About MEDBALTICA： The MEDBALTICA Exhibition in Riga, Latvia, is the largest and most influential medical exhibition in the country. It brings together experts from various health fields, professional associations, and medical product manufacturers from Latvia and abroad.
- Source: drugdu
- 573
- February 4, 2025
Will the National Biopharmaceutical Alliance’s Centralized Procurement Reshape the Biosimilar Market?

As the national biopharmaceutical alliance’s centralized procurement approaches, the biosimilar market is facing a major transformation. On January 14, 2025, the Anhui Provincial Medical Insurance Work Conference clearly stated that it would take the lead in the national biopharmaceutical alliance’s centralized procurement. This move is regarded as an “upgraded version” of biopharmaceutical centralized procurement, covering a wider range of varieties, a larger market scale, and more intense bidding. After the news of the centralized procurement spread, the stock prices of relevant pharmaceutical companies fluctuated. For example, the stock price of Innovent Biologics plummeted by 14% at one point after the news was announced, and the decline at the close was 10.16%. Nevertheless, relevant companies have stated that the centralized procurement has a limited impact on overall revenue, and the companies are planning the launch of new drugs to cope with market changes. Innovent Biologics, Shanghai Henlius Biotech, Junshi Biosciences, etc. ...
- Source: drugdu
- 577
- February 3, 2025
The possibility of fraud is small, and it is recommended that generic drugs do a good job in the daily sampling inspection of consistency evaluation

On January 24th, an online article “A large number of similar data in the consistency evaluation of generic drugs” caused a heated discussion. The author gave three varieties as examples, such as rosuvastatin calcium tablets, where the bioequivalence test data of the two production enterprises, Nanjing Chia Tai Tianqing and Lek Pharmaceuticals d.d, were completely the same; among the 6 generic drugs that passed the consistency evaluation of trametazidine hydrochloride tablets, the data of Hubei Sihuan and Grand Pharma also appeared to be the same; and the BE fasting data of metformin hydrochloride tablets of Guizhou Tian’an Pharmaceutical was consistent with the data of Shanghai Shangyao Xinyi Pharmaceutical Factory. The author also stated in the article that it is very difficult and requires very high standards for a generic drug to pass the consistency evaluation formally. There are tens of thousands of generic drugs in our country, and only 1,988 ...
- Source: drugdu
- 322
- February 3, 2025
Novo Nordisk Surged by Over 10% at One Point as New Weight – loss Drug Amycretin’s Trial Data Shines

On January 24, Novo Nordisk, the Danish pharmaceutical giant, announced the latest trial results of the new weight – loss drug Amycretin. This drug can, on average, help patients lose 22% of their body weight, outperforming Semaglutide, which the company is currently marketing. Boosted by this news, Novo Nordisk’s shares on the US stock market opened with a surge of over 10% on Friday. As of the time of writing, the increase had dropped back to over 8%. The trial results showed that Amycretin is administered by injection. After 36 weeks, the average body weight of obese and overweight patients decreased by 22%. In contrast, patients using a placebo during the same period gained 2.0% in body weight. This trial involved 125 overweight or obese patients. The most common side effect was gastrointestinal discomfort, and most of the side effects were evaluated as “mild to moderate”. Compared with the already ...
- Source: drugdu
- 423
- February 3, 2025
Chengda Biotech’s Quadrivalent Influenza Vaccine Accepted by the Drug Administration

On January 24, it was reported that Chengda Biotech (688739) announced that the application for marketing approval of the quadrivalent influenza virus split vaccine developed by its wholly – owned subsidiary, Chengda Biotech (Benxi) Co., Ltd., for domestic drug production and registration had recently received the “Acceptance Notice” from the National Medical Products Administration. This vaccine is used to prevent influenza caused by influenza viruses of vaccine – related types. It has good safety and immunogenicity and can stimulate the body to produce immunity against influenza viruses. If the quadrivalent influenza vaccine is successfully approved for marketing, it will enrich the company’s product pipeline, enhance the company’s core competitiveness, and lay a foundation for the company’s sustainable and stable development. At the same time, the announcement pointed out that the acceptance of this application will not have a significant impact on the company’s recent performance. In addition, the review and ...
- Source: drugdu
- 431
- February 3, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.