regulatory_update

CelluPro Becomes First China Cell Culture Media Maker With EXCiPACT GMP

Yantai – September 09, 2026 -- CelluPro has secured EXCiPACTTM GMP certification for pharmaceutical auxiliary materials, becoming the first China-based cell culture media supplier to achieve the credential.

CelluPro adds EXCiPACT GMP to existing ISO certification portfolio

The biotechnology firm, which specializes in serum-free cell culture media and bioprocessing solutions, now holds EXCiPACTTM certification alongside ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 22301 certifications covering quality management, environmental management, occupational health and safety, and business continuity.

NGO Warns AfD's Saxony-Anhalt Win Threatens Healthcare Access

Munich – – September 09, 2026 -- Medical relief organization Ärzte der Welt has warned that the AfD's election victory in Saxony-Anhalt could jeopardize healthcare access for vulnerable populations across Germany, citing risks to uninsured patients, refugee families and homeless individuals.

AfD's potential Bundesrat entry raises funding risks for uninsured care

Ärzte der Welt Director Katri Bertram said that if the AfD takes over the state government and enters the Bundesrat, it could endanger patient health in Magdeburg and nationwide. She specifically flagged risks to families fleeing war zones, homeless people and those in poverty, warning that increased exclusion could worsen population-wide health outcomes, including unchecked infectious diseases.

14 German Welfare Groups Warn Against 2027 Social Budget Cuts

Berlin – September 09, 2026 -- A coalition of 14 German welfare, union and environmental organizations has issued a joint appeal to the Bundestag during its budget week, demanding sufficient funding for core social policy tasks in the 2027 federal budget.

Coalition flags cuts to pension and health insurance subsidies

The Sozialstaatsbündnis, which includes Sozialverband VdK Deutschland, DGB, ver.di, IG Metall, Caritas, AWO, Diakonie, Volkssolidarität, Deutscher Mieterbund, Der Paritätische, BUND, ZWST, ASB and SoVD, said planned reductions in federal subsidies to pension and health insurance systems risk weakening social security frameworks during a period of economic uncertainty.

CelluPro Becomes First China Firm to Win EXCiPACT GMP Certification

Yantai – September 09, 2026 -- CelluPro has become the first Chinese cell culture media supplier to receive EXCiPACTTM GMP Certification for Pharmaceutical Auxiliary Materials, adding an internationally recognized quality benchmark to its biomanufacturing supply chain.

EXCiPACT Certification Validates Manufacturing Controls and Traceability

The EXCiPACTTM scheme sets GMP requirements for materials used in biopharmaceutical manufacturing, assessing quality management, manufacturing controls, traceability, and supply chain practices. CelluPro's certification adds to an existing compliance portfolio that includes ISO 9001, ISO 13485, ISO 14001, ISO 45001, and ISO 22301, covering quality management, environmental management, occupational health and safety, and business continuity.

PAL-V Secures EU Production Approval for Flying Cars

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PAL-V Secures EU Production Approval for Flying Cars

Raamsdonksveer, Netherlands – September 09, 2026 -- Dutch company PAL-V has obtained European Production Organisation Approval (POA), becoming the first company in the FlyDrive segment of Advanced Air Mobility to hold both automotive and aviation production approvals for industrial-scale manufacturing.

PAL-V now holds dual approval to manufacture aviation products under EASA regulations

The POA authorizes PAL-V to build airworthy products under EASA rules, following a "No Technical Objection" issued by EASA in 2025. The company states its production system now meets EASA's stringent requirements for airworthy manufacturing, a milestone it describes as the result of nearly two decades of certification and regulatory development.

Fosun International Hits Record AA+ in Hang Seng Sustainability Rating

Hong Kong – September 09, 2026 -- Fosun International Limited (HKEX: 00656) has had its Hang Seng Sustainability Rating upgraded from AA- to AA+, a record high for the Group, following the 2026 ratings review by Hang Seng Indexes Company Limited that took effect the same day.

Rating upgrade breaks three-year plateau at AA-

Fosun had held the AA- rating for three consecutive years before this year's jump to AA+. The Hang Seng Sustainability Rating covers approximately 500 Hong Kong-listed companies within the Hang Seng Composite Index and more than 1,300 A-share companies in the Hang Seng China A (Investable) Index, based on a framework developed by the Hong Kong Quality Assurance Agency assessing seven core indicators including corporate governance, environment and fair operating practices.

TÜV Group Builds AI Trust Certification, Launch Set for Late 2026

Berlin – September 09, 2026 -- Germany's TÜV testing organizations are building a joint certification framework for artificial intelligence systems, with market rollout targeted for late 2026, as new survey data shows 79 percent of German citizens fear uncalculable risks from AI.

Survey shows trust gap even among active AI users

According to the TÜV Association's 2025 AI study, a representative survey conducted around October 26, 2025, 79 percent of German citizens fear unpredictable AI risks. Among people who actively use AI applications, only 53 percent trust that the results and answers produced are correct.

Softcare Hosts ASN, ISO, SIS Delegation at Senegal Hygiene Plant

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Softcare Hosts ASN, ISO, SIS Delegation at Senegal Hygiene Plant

Dakar – September 09, 2026 -- Softcare opened its Senegal manufacturing site to a technical delegation from the Senegalese Standardization Association (ASN), the International Organization for Standardization (ISO) and the Swedish Institute for Standards (SIS), part of a stakeholder assessment targeting the country's menstrual hygiene product sector.

Delegation reviews production capacity and quality systems at Softcare's Senegal factory

The visit forms part of the project "Strengthening the Application and Compliance with International Standards for Menstrual Hygiene Products — Stakeholder Needs Assessment," which aims to map capacities, needs and constraints across Senegal's hygiene product value chain. The initiative also feeds into ongoing reinforcement of the country's National Quality Infrastructure (INQ).

Cologne Court Upholds Injunction Against AEKE Over Gym Monster Design

Shenzhen – September 09, 2026 -- The Cologne Regional Court has upheld an interim injunction against Shenzhen Qudong Future Technology Co., Ltd. ("AEKE") for infringing a registered EU design held by Shenzhen Speediance Life Tech Limited ("Speediance") for its Gym Monster smart strength training system, barring AEKE from advertising, offering or selling the disputed equipment in Germany.

Court confirms original injunction remains fully effective
Ruling in Case No. 31 O 132/26, the Landgericht Köln confirmed that its April 17, 2026 order against AEKE stands in its entirety following a June 25, 2026 hearing triggered by AEKE's challenge. The court also ordered the removal of the disputed products and related marketing materials from the German market.

Potomac Edison Seeks $52.8M Maryland Rate Hike for Grid Upgrades

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Potomac Edison Seeks $52.8M Maryland Rate Hike for Grid Upgrades

Williamsport, Md. – September 09, 2026 -- Potomac Edison, a FirstEnergy Corp. (NYSE: FE) subsidiary, has filed a $52.8 million rate adjustment proposal with the Maryland Public Service Commission that would raise the average residential customer's monthly bill by approximately 5.3%.

Even after the increase, Potomac Edison's residential rates would remain the lowest among Maryland's investor-owned electric utilities. As of June 1, the utility's rates stood 25% below the average of its in-state peers.