The Implementation of the 2020 Roadmap to Promote Good Registration Management (GRM) in APEC Region.

Background: To promote the efficiency and quality of registration for medical products, the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) has implemented a 2020 roadmap to promote the concept of GRM since 2011. Key outcomes of this roadmap are discussed in this article to provide recommendations for improved regulatory practices and accelerated regulatory convergence.

Methods: Adoption of relevant guidelines and delivery of training programs from the APEC Training Centers of Excellence for Regulatory Science (CoEs) have played a key role to promote capacity building, cooperation and convergence in good review practices (GRevPs) and good submission practices (GSubPs) for medical products among APEC economies.

APEC Workshop Report of Good Review Practices on Medical Products.

As part of the implementation of the 2020 Good Review Practices (GRevP) Roadmap championed by Chinese Taipei in the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC), the Taiwan Food and Drug Administration (TFDA) organized 2 workshops. The purpose of these workshops was to address the fundamental elements of a well-designed regulatory review system, to provide complementary modules for GRevP and approaches to the exchange and the use of product assessment reports between regulatory authorities, and to further promote regulatory efficiencies and best practices. The workshops brought together 81 regulatory representatives from 15 economies for the basic workshop and 133 from 20 economies for the advanced workshop.

N-terminal functional domain of Gasdermin A3 regulates mitochondrial homeostasis via mitochondrial targeting.

Background: The epidermis forms a critical barrier that is maintained by orchestrated programs of proliferation, differentiation, and cell death. Gene mutations that disturb this turnover process may cause skin diseases. Human GASDERMIN A (GSDMA) is frequently silenced in gastric cancer cell lines and its overexpression has been reported to induce apoptosis.

Differential response of epithelial stem cell populations in hair follicles to TGF-β signaling.

Epidermal stem cells residing in different locations in the skin continuously self-renew and differentiate into distinct cell lineages to maintain skin homeostasis during postnatal life. Murine epidermal stem cells located at the bulge region are responsible for replenishing the hair lineage, while the stem cells at the isthmus regenerate interfollicular epidermis and sebaceous glands. In vitro cell culture and in vivo animal studies have implicated TGF-β signaling in the maintenance of epidermal and hair cycle homeostasis.

Copper emission during thermal treatment of simulated copper sludge.

This study evaluates Cu emissions in air-particulate and gas phases during thermal treatment of simulated copper sludge by a rotary kiln. Influences of operating parameters, including treatment temperature (400-700 degrees C), rotary speed (0.89-2.

Notch signaling prevents mucous metaplasia in mouse conducting airways during postnatal development.

Goblet cell metaplasia and mucus overproduction contribute to the pathogenesis of chronic lung diseases, including asthma and chronic obstructive pulmonary disease (COPD). Notch signaling regulates cell fate decisions and is crucial in controlling goblet cell differentiation in the gut epithelium. Little is known, however, about how endogenous Notch signaling influences the goblet cell differentiation program that takes place in the postnatal lung.

Notch signaling regulates late-stage epidermal differentiation and maintains postnatal hair cycle homeostasis.

Background: Notch signaling involves ligand-receptor interactions through direct cell-cell contact. Multiple Notch receptors and ligands are expressed in the epidermis and hair follicles during embryonic development and the adult stage. Although Notch signaling plays an important role in regulating differentiation of the epidermis and hair follicles, it remains unclear how Notch signaling participates in late-stage epidermal differentiation and postnatal hair cycle homeostasis.