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【EXPERT Q&A】Does European GPSR compliance require CE certification?

Drugdu.com expert’s response: Happy Chinese New Year! Detailed Analysis on the Relationship Between GPSR Compliance and CE Certification in Europe I. Concepts and Relationship Between GPSR and CE Certification GPSR (General Product Safety Regulation): It is a regulation of the European Union concerning the general safety of products, aiming to ensure that products placed on the EU market are safe under normal or reasonably foreseeable conditions of use. It covers a wide range of product categories, including toys, electrical appliances, and various consumer goods, requiring products to meet corresponding safety, health, and environmental standards. CE Certification: It constitutes the “essential requirements” of European directives and is considered as the “passport” for manufacturers to enter the European market. It indicates that the product complies with the basic requirements of the EU’s “New Approach to Technical Harmonization and Standardization” directives, involving mechanical safety, electromagnetic compatibility, low-voltage safety, and other aspects. Relationship: Partial ...
- Source: drugdu
- 503
- January 29, 2025
HEALTH EXPO IRAQ

Organiser：IFP IRAQ Time：September 18th – 21st, 2025 Address：Baghdad International Exhibition Center, Baghdad, Iraq Exhibition hall：Baghdad International Exhibition Center, Iraq Product range: Medical equipment, medical engineering, diagnostic equipment, operating room instruments, emergency & rescue equipment, biology, medical manufacturing and control equipment, laboratory instruments and equipment, medical products, new technologies & equipment, equipment needed for hospitals & nursing homes, emergency medical supplies, surgical medical supplies for hospitals, modern information technology for healthcare services About HEALTH EXPO IRAQ： The Health Expo Iraq, held in Baghdad, is a representative and large-scale international exhibition on hospital medical device technology in Iraq.
- Source: drugdu
- 650
- January 28, 2025
Without the consent of independent H-share shareholders, Henlius privatization terminated

On January 22, Fosun Pharma issued an evening announcement stating that the special resolution on the privatization of Henlius by its holding subsidiary Fosun New Drug through absorption merger was not approved at the H-share class shareholders’ meeting. Therefore, the absorption merger will not be implemented and Henlius will retain its H-share listing status. The announcement showed that the proposal was mainly opposed by small and medium-sized shareholders. At the interim shareholders’ meeting of Henlius, it was approved by more than two-thirds (including the number) of shareholders with voting rights who attended the meeting, but at the class shareholders’ meeting where only H-share shareholders had voting rights, the proportion of dissenting votes reached 19.25%, exceeding the 10% upper limit stipulated in the acquisition regulations. Fosun Pharma said that it regretted the failure of the Henlius privatization proposal and fully respected the decision of all shareholders. Fosun Pharma will continue to ...
- Source: drugdu
- 470
- January 27, 2025
Another ADC drug is approved for marketing

Recently, the FDA officially approved Datroway (datopotamab deruxtecan, Dato-DXd), an innovative antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for the treatment of unresectable or metastatic hormone receptor (HR)-positive, HER2-negative adult breast cancer patients who have received endocrine therapy and chemotherapy. The key basis for the approval of Dato-DXd for breast cancer indications was the positive results of its Phase III clinical study TROPION-Breast01. In the TROPION-Breast01 study, Dato-DXd showed efficacy advantages. Compared with the standard therapy selected by the researchers, the drug successfully reduced the risk of disease progression or death in patients by 37%. This data means that in patients treated with Dato-DXd, the rate of disease deterioration has slowed significantly, giving patients more survival time and treatment opportunities. Specifically, progression-free survival (mPFS) was significantly extended from 4.9 months in the control group to 6.9 months in the trial group. In terms of safety assessment, a key concern ...
- Source: drugdu
- 282
- January 27, 2025
【EXPERT Q&A】How effective is Telitacicept?

Drugdu.com expert’s response: Telitacicept, a novel fusion protein drug for the treatment of autoimmune diseases, has demonstrated its therapeutic efficacy in multiple clinical trials, as detailed below: I. Main Therapeutic Indications and Effects Systemic Lupus Erythematosus (SLE) Telitacicept alleviates SLE symptoms by inhibiting the overactivation of B cells. Clinical trial data indicate that over 60% of patients using Telitacicept experienced significant improvement in their condition, specifically evident in the relief of skin, joint, and kidney symptoms. A multicenter, randomized, double-blind, placebo-controlled pivotal clinical study showed that the 48-week response rate in the high-dose Telitacicept group was 79.2%, significantly higher than the 32.0% in the placebo control group. Another nationwide multicenter, randomized, double-blind, placebo-controlled Phase IIb drug study showed that the Telitacicept 160mg dose group (the standard dose approved for marketing in China) had significantly higher response rates than the placebo group from Week 12 onwards, and the efficacy advantage persisted ...
- Source: drugdu
- 377
- January 27, 2025
DR is the absolute king, and Wandong leads the industry in cutting-edge innovation

Recently, the 2024 DR equipment public bidding and procurement list was released, and domestic medical equipment won 10 of the 12 lists, marking the transformation of domestic substitution towards innovative applications. Wandong Medical has the highest market share and has dominated the list for more than ten consecutive years, deserving the title of DR King. In fact, the overall situation of DR equipment in 2024 is not optimistic. According to statistics from Zhongcheng Data Science, the overall market size of medical device bidding in China decreased by 21.1% year-on-year in 2024, with the DR equipment market also decreasing by 21.5%. The reasons for the decline are the multiple impacts of medical policies, technological innovations, and competitive trends. From the perspective of procurement trends, the market is divided into two levels: centralized procurement and high-level hospitals, which means higher requirements are placed on domestic medical equipment. It is worth mentioning that ...
- Source: drugdu
- 331
- January 26, 2025
drugs are replaced by new ones, and companies are competing in the market

On January 22, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the “Influenza Diagnosis and Treatment Plan (2025 Edition)” (hereinafter referred to as the “New Edition”). Compared with the “Influenza Diagnosis and Treatment Plan (2020 Edition)” (hereinafter referred to as the “2020 Edition”), the new version includes two anti-influenza virus drugs, Mabaloxavir and Favipiravir. Amantadine and rimantadine were eliminated due to drug resistance issues. At the same time, the new version of the plan clearly stated that it is not recommended to use antiviral drugs with the same mechanism of action in combination. Many pharmacists pointed out to the 21st Century Business Herald reporter that this move is aimed at optimizing the treatment effect and reducing unnecessary side effects. After the replacement of drugs, more and more companies have seen the development potential of the anti-influenza drug market. Competition in the oseltamivir market has ...
- Source: drugdu
- 990
- January 26, 2025
Under the vaccine price war, Kangtai Biological, which did not reduce prices, had a “turnaround” in its performance last year

On the evening of January 22, Kangtai Biological released its 2024 performance forecast. The performance forecast shows that in 2024, Kangtai Biological will achieve a net profit of 190 million to 270 million yuan, a year-on-year decrease of 77.94% to 68.65%. Last year, this figure was 861 million yuan. Kangtai Biological said that due to market competition, inventory reduction and other factors, the company’s operating income has declined to a certain extent compared with the same period last year; coupled with the increase in fixed asset depreciation expenses, asset impairment, and the termination of the 2023 equity incentive plan to accelerate the exercise of rights, the net profit in 2024 has decreased compared with the same period last year. On January 23, Jiemian News called Kangtai Biological’s secretary’s office. The staff responded that Kangtai Biological’s full range of products has not been reduced in price. Since the unit price of ...
- Source: drugdu
- 357
- January 26, 2025
China’s first monkeypox vaccine officially starts clinical trials

On January 21, the Phase I clinical research launch meeting of the MVA strain monkeypox live attenuated vaccine independently developed by Sinopharm Group China National Biotec Group Shanghai Institute of Biological Products was held at the Henan Provincial Infectious Disease Hospital (Zhengzhou Sixth People’s Hospital). The launch meeting was fully trained and discussed around the clinical trial plan, key points and difficulties of clinical site operations. On September 9, 2024, this monkeypox vaccine obtained the clinical trial notification issued by the State Food and Drug Administration. It is the first monkeypox vaccine approved for clinical trials in my country and is expected to play an important role in the prevention and control of diseases caused by monkeypox virus in my country. On January 22, the first batch of subjects in the Phase I clinical trial of the MVA strain monkeypox live attenuated vaccine were enrolled, marking that my country’s first ...
- Source: drugdu
- 457
- January 26, 2025
Notai Biotech’s Dry Mixed Suspension and Granule Production Lines Pass GMP Compliance Inspection

On January 21, Notai Biotech announced that the dry mixed suspension production line and granule production line in its Zhonghua Pharmaceutical Port factory (Workshop 203) recently received the “Drug GMP Compliance Inspection Notification” (Su Yao Jian Yao Sheng Gao [2025] 037 and [2025] 038) issued by the Jiangsu Provincial Drug Administration, passing the drug GMP compliance inspection. The workshop is designed according to FDA/EMA standards and has introduced first-tier international brand equipment, including Glatt’s wet granulation line, KILIAN’s double-outlet tablet press, SYNTEGON’s capsule filling machine, Glatt’s coating machine, and CAM’s automated packaging line. The designed annual production capacities are 4.5 billion tablets & hard capsules, 36 million bottles of oral dry mixed suspensions & granules, and 450 million bags of granules/powders. The workshop has passed completion acceptance. Notai Biotech stated that the successful GMP compliance inspection of the dry mixed suspension and granule production lines indicates that the production lines ...
- Source: drugdu
- 276
- January 25, 2025

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