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Crizotinol Ointment Approved for Market Launch; Jiudian Topical Products Expands to New Indications

Recently, Jiudian Pharmaceutical’s Crizotinol Ointment officially received registration approval from the National Medical Products Administration, which is considered equivalent to passing the generic drug consistency evaluation. This product is a Class B drug covered by the National Medical Insurance Program and is suitable for the topical treatment of mild to moderate atopic dermatitis in children aged 3 months and older and adults. This approval marks a new breakthrough for Jiudian Pharmaceutical in the field of topical medications, further expanding the therapeutic indications of its topical product portfolio from the anti-inflammatory and analgesic field to the field of skin immune inflammation regulation. Atopic dermatitis is a chronic, relapsing, inflammatory skin disease, and its prevalence among children in my country is showing an increasing trend year by year. For a long time, topical treatment for mild to moderate atopic dermatitis has mainly relied on corticosteroids and calcineurin inhibitors. However, long-term use of ...
- Source: drugdu
- 57
- May 8, 2026
Shanghai Pharmaceuticals’ Rivaroxaban Tablets Receive Thai Drug Registration Certificate

Recently, rivaroxaban tablets produced by Changzhou Pharmaceutical Factory Co., Ltd., a subsidiary of Shanghai Pharmaceuticals, received a drug registration certificate issued by the Thai Food and Drug Administration, and the drug has been approved for marketing. Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat and prevent deep vein thrombosis (DVT); to treat pulmonary embolism (PE); and to prevent venous thromboembolism (VTE) in patients with acute illness. Rivaroxaban tablets were originally developed jointly by Bayer and Janssen and were launched in the United States in 2011. In May 2025, Changzhou Pharmaceutical Factory’s rivaroxaban tablets obtained approval from the U.S. Food and Drug Administration. In October 2025, it obtained a drug registration certificate in Malaysia, and in February 2026, it obtained a drug registration certificate in Singapore. According to IQVIA database, the total sales of rivaroxaban tablets in ...
- Source: drugdu
- 49
- May 8, 2026
【EXPERT Q&A】How to apply for a drug business license? What conditions are needed?

Drugdu.com expert’s response: The process and requirements for obtaining a Pharmaceutical Trading License are as follows: I. Application Process 1. Preparation of Application Materials Pharmaceutical Trading License Application Form: Fill in the enterprise’s basic information and application details truthfully. Copy of the Enterprise’s Business License or Name Pre-approval Notice. Personnel Qualification Certificates: Identity certificates, academic certificates, and professional title certificates of the legal representative, enterprise leader, and quality leader. The quality leader must provide a licensed pharmacist registration certificate (for retail enterprises, the quality leader must be a licensed pharmacist). Qualification certificates for personnel engaged in drug inspection, maintenance, and other positions. Site Proof Materials: Property ownership certificates or lease agreements for the business premises and warehouse. Floor plans of the business premises and warehouse, indicating functional areas such as the pending inspection area, qualified area, and unqualified area, in compliance with the Good Supply Practice for Pharmaceutical Products (GSP). ...
- Source: drugdu
- 68
- May 8, 2026
PMEC China 2026

Organiser：Informa Markets Time：June 16 – June 18, 2026 Address：No. 2345 Longyang Road, Pudong New Area, Shanghai Exhibition hall：Shanghai New International Expo Center Product range: Pharmaceutical machinery, packaging equipment, intelligent manufacturing, pharmaceutical packaging materials, drug delivery devices and accessories, laboratory instruments and equipment, clean equipment and engineering, environmental protection and energy-saving equipment, life science instruments, bioengineering, pharmaceutical logistics equipment and services, equipment accessories About PMEC China： The World Pharmaceutical Machinery, Packaging Equipment and Materials China Expo (PMEC China) serves as a vital platform for product trade and information exchange in the global pharmaceutical industry. PMEC China has consistently been committed to showcasing the high-quality products and exceptional research and development capabilities of Chinese equipment manufacturing companies to the world. Meanwhile, numerous overseas buyers also regard PMEC as an important window for gaining insights into the Chinese market.
- Source: drugdu
- 79
- May 7, 2026
【EXPERT Q&A】What is the process for the production filing of Class I medical devices?

Drugdu.com expert’s response: The process for filing the production of Class I medical devices is as follows: 1. Corporate Qualification Preparation Legal Business License: The enterprise must possess a valid business license, with its business scope covering the production of medical devices. Production Conditions: Ensure that the enterprise has the necessary production conditions, including the configuration of hardware facilities such as factory premises, equipment, and personnel. 2. Product Classification Confirmation Class I Confirmation: Confirm that the product falls under the category of Class I medical devices by referring to the “Medical Device Classification Catalog” or consulting regulatory authorities for confirmation. Re-confirmation upon Changes: If there are changes in the product’s function or intended use, re-confirm its classification to avoid misclassification. 3. Filing Document Preparation Core Documents: Class I Medical Device Production Filing Form Product Technical Requirements Document: Clearly specifying performance indicators and testing methods. Production Quality Management Documents: Demonstrating the ...
- Source: drugdu
- 70
- May 6, 2026
IRAN HEALTH

Organiser：SANAT SALAMAT Newsad CO. Time：June 8 – June 11, 2026 Address：Tehran International Permanent Fairground, Chamran Expressway, Vali-e Asr Ave., Tehran, Iran Exhibition hall：Tehran International Exhibition Center Product range: Hospital equipment and medical devices, surgical instruments and medical-related books, X-ray, CT, MRI, nuclear medicine, imaging technology, pharmaceutical and herbal products, home medical equipment, physiotherapy, pharmaceutical raw materials, anesthesiology, respiratory instruments and equipment, pharmaceutical and packaging equipment, surgical techniques and equipment, healthcare products, sterilization and disinfection equipment, clinical chemistry automation devices, emergency medical equipment and pharmaceuticals, biotechnology laboratory equipment, surgical instruments and endoscopic equipment, blood bank equipment and refrigeration equipment, general and specialized diagnostics, dental care and treatment equipment, orthopedic technology and rehabilitation devices, oral care, consumables, and equipment (disinfection and technology) About IRAN HEALTH： The Iran Health Exhibition & Iran Dental Exhibition (IRAN HEALTH) is the most renowned and largest medical and pharmaceutical themed exhibition in Iran. Each year, ...
- Source: drugdu
- 83
- May 5, 2026
【EXPERT Q&A】Under the EU MDR regulation, what rules are used to determine the classification of medical devices?

Drugdu.com expert’s response: Under the EU Medical Device Regulation (Regulation (EU) 2017/745), the classification of medical devices is primarily based on their intended use and inherent risks, following a detailed set of classification rules that categorize medical devices into four classes: Class I, Class IIa, Class IIb, and Class III. Below are the core principles and logic of this classification system: I. Core Principles of Classification Risk Stratification: The higher the risk level, the stricter the classification and regulatory requirements. Intended Use as the Primary Factor: Classification is based on the manufacturer’s declared intended use, without considering misuse or abuse scenarios. Highest Risk Applies When Multiple Rules Apply: If a single device is subject to multiple classification rules, it is classified according to the rule with the highest risk. Key Factors: Invasiveness, Duration of Use, Active/Non-Active, and Site of Action: Invasiveness: Non-invasive, through body orifices, surgical invasive, implantable. Duration of ...
- Source: drugdu
- 80
- May 4, 2026
【EXPERT Q&A】What is the basic process for applying for a Class II medical device registration certificate?

Drugdu.com expert’s response: The basic process for applying for a Class II medical device registration certificate is as follows: 1. Product Classification Determination and Preliminary Preparations Confirm Product Classification: Verify that the product falls within the scope of Class II medical devices, either by referring to the “Medical Device Classification Catalog” or by applying to the provincial drug regulatory authority for classification determination (which takes approximately 20 working days). Complete Product Development: Conduct product research and development, trial production, testing, and evaluation. Develop production processes and documentation that meet regulatory requirements. Establish a Quality Management System: Ensure compliance with the “Good Manufacturing Practice (GMP) for Medical Device Production,” covering all aspects such as design and development, production, and inspection. 2. Product Inspection and Clinical Evaluation Full-Performance Inspection: Conduct type testing at a testing institution with CMA/CNAS accreditation (such as provincial medical device testing institutes). The testing cycle typically ranges from ...
- Source: drugdu
- 81
- May 1, 2026
CPhI China 2026

Organiser：Informa Markets Time：June 16 – June 18, 2026 Address：No. 2345 Longyang Road, Pudong New Area, Shanghai Exhibition hall：Shanghai New International Expo Center Product range: Core Raw Materials and Ingredients: Pharmaceutical raw materials, intermediates, fine chemicals, pharmaceutical excipients, veterinary drugs and feed additives, vitamins, amino acids and their derivatives, hormones, antibiotics, antipyretic and analgesic drugs, cardiovascular drugs, central nervous system drugs, respiratory drugs, digestive drugs, anti-parasitic drugs Natural Products and Extracts: Plant extracts, animal extracts, traditional Chinese medicine raw materials, health food raw materials, functional food raw materials, food and beverage raw materials, beauty and cosmetic raw materials Biotechnology and Pharmaceutical Services: Biological products and emerging therapies, peptide drugs, cell therapy, gene editing technology, biotechnology, bioengineering, life science instruments, pharmaceutical outsourcing services, contract customization Preparations and Finished Drugs: Preparations, veterinary drug preparations, respiratory drugs, anesthetic drugs, other western drug raw materials Pharmaceutical Machinery and Equipment: Pharmaceutical machinery and packaging equipment, ...
- Source: drugdu
- 148
- April 30, 2026
【EXPERT Q&A】What conditions are required to apply for a medical device registration certificate?

Drugdu.com expert’s response: The following conditions must be met for the application of a medical device registration certificate: I. Corporate Qualifications and Legitimacy The applicant must be a legally registered enterprise with a corresponding business scope and provide a valid business license. Enterprises involved in production activities are required to hold a Medical Device Production License (some categories may be exempted). For applications from overseas enterprises, it is necessary to provide medical device production qualification certificates and marketing authorization documents from their home countries (regions). II. Quality Management System The enterprise needs to establish a quality management system that complies with medical device production quality management regulations (such as ISO 13485). The system should cover the entire process, including product design, production, inspection, and sales, and be staffed with full-time quality management personnel. Provide quality management system documents, including procedural documents on management responsibilities, resource management, product realization, etc. III. ...
- Source: drugdu
- 84
- April 29, 2026

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