Disinfectant & Biocide

FDA Withdraws Temporary Guidance for Hand Sanitizers

Companies may no longer manufacture under Temporary Guidance beyond December 31, 2021 The Temporary Emergency Use Authorization (EUA) on hand sanitizers was first authorized by the US FDA in March ...

2021-12-23

Disinfectant & Biocide

China Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)

On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements ...

2021-12-17

Pharmaceutical

New Market Entry Pathways of Medical Products: Special Medical Zones in China

In China, many patients resort to unconventional means of receiving treatment for their diseases, like going abroad or relying on surrogate shoppers. According to a New York Times article, in 2017, ...

2021-11-19

Pharmaceutical

China to Implement Good Pharmacovigilance Practices

China National Medical Products Administration (NMPA) officially issued the Good Pharmacovigilance Practices (GVP) on May 13, 2021, after releasing the consultation draft in December last year. GVP, ...

2021-11-19

Pharmaceutical

Expedited Programs for Drug Registration in China

According to China's Administrative Measures for Drug Registration enacted since July 1, 2020, the National Medical Products Administration (NMPA) shall launch expedited programs for drug ...

2021-11-19

Pharmaceutical

China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials

China's drug review & approval system has undergone substantial reforms since it joined the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human ...

2021-11-19

Pharmaceutical

CRAC-HCF 2021： Embracing China's Pharma Market With Regulatory Compliance and Industry Insights

China's Drug Regulation and Pharmaceutical Market Conference, a sub-event of CRAC-HCF 2021 (Chemical Regulatory Annual Conference and Asian Helsinki Chemicals Forum), concluded on Nov. 12.Five ...

2021-11-17

Industrial Chemical

CRAC-HCF 2021 Highlights: India Expects to Notify WTO of Draft CMSR This Year

India’s national chemical management policy has been in the spotlight since the unveiling of the fifth draft of the Chemicals (Management and Safety) Rules (CMSR) in August 2020.So when Mr. Shisher ...

2021-11-16

Industrial Chemical

CRAC-HCF 2021 Highlights: Compliance Challenges and Preparation of TSCA for Future Restrictions

In 2016 under the Obama administration, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) was signed into law. The Lautenberg Chemical Safety ...

2021-11-16

Industrial Chemical

CRAC-HCF 2021 Highlights：Current Status and Challenges of EU Nanomaterials Registration

With the rapid development of nanotechnology, nanomaterials are now widely used across many fields. Although nanomaterials offer technical and commercial opportunities, they may also pose risks to ...

2021-11-16