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【EXPERT Q&A】How can clinical evaluations be carried out efficiently under the EU MDR regulation?

Drugdu.com expert’s response: Under the EU MDR Regulation, the core of efficiently carrying out clinical evaluation is to avoid repeated rectification in the later stage and greatly shorten the compliance cycle through advance planning, process standardization and pre-risk control. Below are the directly implementable efficient methods: 1. Build a Standardized Clinical Evaluation Plan (CEP) in Advance ‌Clarify core elements‌: Directly anchor the general safety and performance requirements supported by clinical data, the precise target patient population of the product, and quantifiable clinical benefit indicators in the plan to avoid repeated supplementation in subsequent stages. ‌Align compliance boundaries in advance‌: Proactively align with the requirements of MDR Annex XIV and MDCG 2021-6 guideline, so as to avoid common problems caused by missing plan elements from the very beginning. ‌Reserve a gap prediction session‌: Preset the execution nodes for literature retrieval and data assessment in advance, to identify potential clinical evidence gaps ...
- Source: drugdu
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- August 21, 2026
CPhI Korea

Organiser：Informa Markets Time：August 25 – 27, 2026 Address：COEX Convention & Exhibition Center Exhibition hall：513 Yeongdong-daero, Gangnam District, Seoul, Republic of Korea Product range: Active Pharmaceutical Ingredients (APIs)‌: Vitamins, Hormones, Sulfonamides, Antipyretic Analgesics, Tetracyclines, Amino Acids and Their Derivatives, Chloramphenicols, Digestive System Medications, Other Anti-Infective Agents, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular System Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Medications, Central Nervous System Medications, Other Western Pharmaceutical Raw Materials ‌Excipients and Dosage Forms‌: Excipients, Glidants, Enteric-Coating Materials, Antioxidants, Sweeteners, Penetration Enhancers, Preservatives, Disintegrants, Coating Materials, Surfactants, Opacifiers, Flavors, Filter Aids, Stabilizers, Lubricants, Plasticizers, Solvents, Flavor Correctors, Colorants, Clarifying Agents, pH Regulators, Others ‌Natural Extracts‌: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Raw Materials, Functional Food Raw Materials, Health Supplement Raw Materials, Nutraceutical Raw Materials, Dietary Supplements, Dietary Fiber, Cosmetic Raw Materials About CPhI Korea ： CPhI Korea was first launched in 2014. Adopting an integrated model that organically combines exhibitions, ...
- Source: drugdu
- 44
- August 20, 2026
【EXPERT Q&A】What are the registration requirements for exporting medical devices to Brazil?

Drugdu.com expert’s response: For medical devices exported to Brazil, ‌all products that enter the Brazilian market for circulation, sale and clinical use must complete ANVISA-related registration/notification, which is a mandatory pre-requisite for legal entry, and there is no general compliance exemption‌. Below is the complete latest 2026 registration requirements: 1. Core Regulatory Basic Requirements ‌Regulatory Authority‌: All medical devices are uniformly regulated by the Brazilian National Health Surveillance Agency (ANVISA). Overseas manufacturers cannot submit registration applications directly, and must appoint a ‌Brazilian Local Registration Holder (BRH)‌ with a valid Brazilian CNPJ tax number as the legally responsible entity, who is in charge of submitting technical documents, undertaking post-market adverse event reporting, recall execution and other compliance responsibilities. ‌Basic Legal Basis‌: Anchored in Law 6,360/1976, Law 9,782/1999, supported by technical details such as the RDC 751/2022 risk classification rules and RDC 665/2022 GMP specifications. 2. Risk Classification and Corresponding Registration Paths ...
- Source: drugdu
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- August 19, 2026
Haixi’s new drug HX9428 receives Fast Track designation from the US FDA.

Forwarding our company’s announcement dated August 17, 2026: The Board of Directors of our Company is pleased to announce that HX9428, a drug candidate molecule of our independently developed innovative drug project HXP056, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the development of a treatment for neovascular age – related macular degeneration ( nAMD, also known as wet age-related macular degeneration, wAMD) . This FTD designation will facilitate closer communication between our Company and the FDA regarding the clinical development of HX9428 and advance its global clinical development process. HX9428 is a novel oral small molecule drug independently developed by Haixi New Drug, intended for the treatment of nAMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard treatment for nAMD. However, existing treatments require intravitreal injection into the eye, which may lead to long-term, repeated treatments, resulting in medical ...
- Source: drugdu
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- August 18, 2026
Just now, Fosun Pharma licensed 10 biosimilar drugs for overseas markets!

Just now, Fosun Pharma issued an announcement stating that its holding subsidiary, Henlius Biotech, signed a “Cooperation Framework Agreement” with Sandoz AG , which will allow Henlius Biotech to cooperate with Sandoz AG on the registration, commercialization, development, and production of up to 10 monoclonal antibody ( mAb ) and / or antibody-drug conjugate ( ADC ) biosimilar products or ingredients in relevant overseas regions . The first three collaborative products are HLX05-N , HLX16 , and belimumab biosimilars, with the collaboration scope covering the treatment of all human indications, but limited to indications approved for the original products in the relevant countries / regions of the collaboration area; one potential collaborative product (options have been granted to the collaborators) is HLXTE-HAase1001 . For the first three collaborative products, Henlius may receive up to US$314 million in upfront payments, development milestones and development budget milestones, and sales milestone payments (subject ...
- Source: drugdu
- 60
- August 18, 2026
Lunan Pharmaceutical’s Milrinone Lactate Injection Receives Marketing Approval in Malaysia

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Milrinone Lactate Injection issued by the Malaysian Food and Drug Administration ( NPRA ), marking that the product has officially obtained market access in Malaysia and can be sold and commercialized there. Milrinone lactate injection is a phosphodiesterase inhibitor with both positive inotropic and vasodilatory effects. It is a drug that rapidly improves hemodynamics and is suitable for acute and chronic refractory congestive heart failure caused by ineffective or poorly responded treatment with digitalis, diuretics, and vasodilators. Currently, milrinone lactate injection produced by Lunan Pharmaceutical has been approved for marketing in the United States, Ukraine, Costa Rica, and other countries. Furthermore, marketing applications have been submitted in more than 20 countries and regions, including Vietnam, Saudi Arabia, Brazil, and the United Kingdom. During the product’s marketing application process in Malaysia, the ...
- Source: drugdu
- 50
- August 18, 2026
Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Pakistan.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate (registration number: 135844) for inhaled isoflurane issued by the Drug Regulatory Authority of Pakistan (DRAP) , marking that the product has officially obtained market access in Pakistan and can be sold and commercialized there. Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia. With its advantages of rapid induction, rapid recovery, and low metabolic rate , it is widely used in various surgical procedures. Currently, this product is available in China, the United States, and Japan, and registration applications are underway in several overseas markets. The company is accelerating its global supply strategy to provide patients with a safe and effective anesthetic option. During the registration process in Pakistan, the registration team strictly adhered to local regulations, efficiently prepared technical documentation, and communicated with reviewers, leading to the successful ...
- Source: drugdu
- 50
- August 18, 2026
BMS’s new anti-tumor drug has been approved for marketing; GSK and Acyclovir are advancing clinical trials of their new drugs.

On August 13 local time , Bristol Myers Squibb ( BMS ) announced that the U.S. FDA has approved its innovative drug Iberdomide ( Zenbexus ) for marketing in combination with the standard treatment regimen (daratumumab + dexamethasone) for the treatment of relapsed or refractory multiple myeloma ( MM ) . According to the press release, Iberdomide is the first FDA -approved cereblon E3 ubiquitin ligase modulator ( CELMoD ) therapy. Iberdomide is the first product in BMS’ CELMoD pipeline. Previously, the drug received Breakthrough Therapy Designation and Priority Review designation from the FDA for the treatment of relapsed or refractory multiple myeloma. This approval is based on the results of the Phase III EXCALIBER-RRMM ( NCT04975997 ) study . This was a Phase III , multicenter, two-stage, randomized, open-label study designed to evaluate the efficacy and safety of the Iberdomide plus daratumumab and dexamethasone (ZDd) regimen versus the daratumumab, ...
- Source: drugdu
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- August 18, 2026
Qilu Pharmaceutical’s Vitamin K1 Injection Approved for Marketing; Mixed Micelle Technology Enhances Drug Safety and Stability

Recently, Qilu Pharmaceutical’s Vitamin K1 injection (Changshi®) received approval from the National Medical Products Administration for marketing and is considered to have passed the consistency evaluation. This approval further enriches the company’s product pipeline in the field of anticoagulant drugs, providing new domestically produced drug options for clinical use. Qilu Pharmaceutical’s R&D personnel conduct formulation process research Normal blood clotting function is essential for maintaining human life. Vitamin K1 is an essential coenzyme for the liver to synthesize four clotting factors (II, VII, IX, and X), playing an irreplaceable core role in the body’s clotting and hemostasis processes. Clinically, excessive use of oral anticoagulants such as warfarin, obstructive jaundice, bile leakage, chronic diarrhea, or long-term use of broad-spectrum antibiotics can all lead to insufficient vitamin K synthesis or intake, causing abnormal blood clotting function, requiring timely exogenous vitamin K1 supplementation to correct the problem. Currently, there is a large number ...
- Source: drugdu
- 50
- August 18, 2026
MFC Medical Fair China

Organiser：Messe Düsseldorf Time：August 20 – 22, 2026 Address：No. 688, East Suzhou Avenue, Suzhou Industrial Park, Suzhou City Exhibition hall：Shenyang International Exhibition Center Product range: In Vitro Diagnosis & Point-of-Care Testing Home-use and Wearable Medical Devices Medical Electronic Equipment Medical Device Manufacturing Equipment Medical Consumables Raw Materials and Components Smart Healthcare Minimally Invasive and Implantable Interventional Devices Medical Innovation Services Others About Medical Fair China (MFC) ： As the exclusive subsidiary exhibition of MEDICA — the world’s largest medical equipment trade show — in China, Medical Fair China (MFC) is themed “From Innovation to Application, Empowering Medical Transformation and Global Expansion”. It brings together leading global medical technology enterprises, scientific research institutions and clinical experts to build an international platform for showcasing medical innovation achievements and industrial chain collaboration, helping enterprises expand markets, connect resources, gain insights into trends and embrace the future. With the rapid iteration of global medical ...
- Source: drugdu
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- August 18, 2026

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