Joint Medicines Regulatory Procedure in the East African Community: Registration Timelines and Way Forward

A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review the dossier was 391 days and the minimum time was 44 days. For applicants, the maximum time to respond to queries was 927 days and the minimum time was nine days. The total median time for granting marketing authorisation by the National Medicines Regulatory Authorities (NMRA) decreased from 174 to 39 working days in 2015 and 2019 respectively. However, not all EAC NMRA has granted marketing authorisation to all 57 products due to non-payment of applicable fees by applicants. Long regulatory approval timelines were contributed by limited capacity for timely scientific review of dossier by some NMRA, lack of online portal to share dossiersand assessment reports, delay in responding to queries by applicants and deficiencies in dossier. The metric tool and register of medical products submitted for joint scientific review had incomplete data. Challenges were identified and actions recommended to ensure regional regulatory system optimization, efficiency, transparency, sustainability and accountability

Butyrate Attenuates Lipopolysaccharide-Induced Inflammation in Intestinal Cells and Crohn's Mucosa through Modulation of Antioxidant Defense Machinery

Oxidative stress plays an important role in the pathogenesis of inflammatory bowel disease (IBD), including Crohn's disease (CrD). High levels of Reactive Oxygen Species (ROS) induce the activation of the redox-sensitive nuclear transcription factor kappa-B (NF-κB), which in turn triggers the inflammatory mediators. Butyrate decreases pro-inflammatory cytokine expression by the lamina propria mononuclear cells in CrD patients via inhibition of NF-κB activation, but how it reduces inflammation is still unclear. We suggest that butyrate controls ROS mediated NF-κB activation and thus mucosal inflammation in intestinal epithelial cells and in CrD colonic mucosa by triggering intracellular antioxidant defense systems. Intestinal epithelial Caco-2 cells and colonic mucosa from 14 patients with CrD and 12 controls were challenged with or without lipopolysaccaride from Escherichia Coli (EC-LPS) in presence or absence of butyrate for 4 and 24 h. The effects of butyrate on oxidative stress, p42/44 MAP kinase phosphorylation, p65-NF-κB activation and mucosal inflammation were investigated by real time PCR, western blot and confocal microscopy. Our results suggest that EC-LPS challenge induces a decrease in Gluthation-S-Transferase-alpha (GSTA1/A2) mRNA levels, protein expression and catalytic activity; enhanced levels of ROS induced by EC-LPS challenge mediates p65-NF-κB activation and inflammatory response in Caco-2 cells and in CrD colonic mucosa. Furthermore butyrate treatment was seen to restore GSTA1/A2 mRNA levels, protein expression and catalytic activity and to control NF-κB activation, COX-2, ICAM-1 and the release of pro-inflammatory cytokine. In conclusion, butyrate rescues the redox machinery and controls the intracellular ROS balance thus switching off EC-LPS induced inflammatory response in intestinal epithelial cells and in CrD colonic mucosa

Meningkatkan Kemampuan Kognitif dalam Mengetahui Sebab Akibat Melalui Kegiatan Membuat Minuman Berbagai Rasa

Dilakukan penelitian ini untuk meningkatkan kemampuan kognitif dalam mengetahui sebab akibat melalui kegiatan membuat minuman berbagai rasa, penelitian ini dilakukan di TK Dharma Wanita Desa kedak Kecamatan semen Kabupaten Kediri, metode yang digunakan dalam penelitian ini adalah penelitian tindakan kelas, penelitian ini menggunakan siklus 1 dan siklus 2 dalam proses untuk meningkatkan kemampuan kognitif peserta didik Dan dari hasil data yang telah diperoleh menunjukkan bahwa peningkatan kemampuan kognitif peserta didik mengalami kenaikan secara baik dimulai dari siklus 1 sampai siklus 2, Hasil tersebut tidak akan bisa berjalan baik jika dalam aspek yang digunakan tidak dikaitkan dengan permainan sebab akibat dalam kegiatan membuat minuman berbagai rasa.Dilakukan penelitian ini untuk meningkatkan kemampuan kognitif dalam mengetahui sebab akibat melalui kegiatan membuat minuman berbagai rasa, penelitian ini dilakukan di TK Dharma Wanita Desa kedak Kecamatan semen Kabupaten Kediri, metode yang digunakan dalam penelitian ini adalah penelitian tindakan kelas, penelitian ini menggunakan siklus 1 dan siklus 2 dalam proses untuk meningkatkan kemampuan kognitif peserta didik Dan dari hasil data yang telah diperoleh menunjukkan bahwa peningkatan kemampuan kognitif peserta didik mengalami kenaikan secara baik dimulai dari siklus 1 sampai siklus 2, Hasil tersebut tidak akan bisa berjalan baik jika dalam aspek yang digunakan tidak dikaitkan dengan permainan sebab akibat dalam kegiatan membuat minuman berbagai rasa

MENINGKATKAN KEMAMPUAN KOGNITIF DALAM MENGETAHUI SEBAB AKIBAT MELALUI KEGIATAN MEMBUAT MINUMAN BERBAGAI RASA

Dilakukan penelitian ini untuk meningkatkan kemampuan kognitif dalam mengetahui sebab akibat melalui kegiatan membuat minuman berbagai rasa, penelitian ini dilakukan di TK Dharma Wanita Desa kedak Kecamatan semen Kabupaten Kediri, metode yang digunakan dalam penelitian ini adalah penelitian tindakan kelas, penelitian ini menggunakan siklus 1 dan siklus 2 dalam proses untuk meningkatkan kemampuan kognitif peserta didik Dan dari hasil data yang telah diperoleh menunjukkan bahwa peningkatan kemampuan kognitif peserta didik mengalami kenaikan secara baik dimulai dari siklus 1 sampai siklus 2, Hasil tersebut tidak akan bisa berjalan baik jika dalam aspek yang digunakan tidak dikaitkan dengan permainan sebab akibat dalam kegiatan membuat minuman berbagai rasa.&#x0D; Kata Kunci: Kemampuan Kognitif, Membuat Minuman Berbagai Rasa, Peserta Didik&#x0D;  </jats:p

Solidaritas Pangan Jogja sebagai Aktor Alternatif Penyedia Kesejahteraan di Masa Krisis Pandemi COVID-19

Tulisan ini membahas munculnya aktor alternatif berbasis jaringan dukungan sosial di tengah keterbatasan negara dalam menyediakan jaring pengaman saat krisis berlangsung. Dengan menggunakan kerangka teori informal security regime dan jaringan dukungan sosial, tulisan ini bertujuan untuk menjelaskan bagaimana Solidaritas Pangan Jogja (SPJ) bergerak dalam mendistribusikan makanan untuk pekerja informal dan kelompok rentan di Yogyakarta saat krisis akibat pandemi COVID-19. Penelitian dilakukan dengan metode kualitatif melalui pendekatan studi kasus dengan analisis deskriptif. Penelitian menunjukkan bahwa SPJ merupakan aktor alternatif yang berbasis jaringan dukungan sosial dan berperan sebagai jaring pengaman dengan memenuhi kebutuhan dasar berupa makanan. Tulisan ini berargumen bahwa meskipun gerakan yang dilakukan dapat memberikan bantuan dengan cepat, gerakan semacam ini juga memiliki kerapuhan dalam hal sumber daya manusia dan sumber daya finansial. Kerapuhan tersebut membuat praktik jaringan dukungan sosial seperti SPJ merupakan model yang tidak permanen dan mudah berubah

Joint Medicines Regulatory Procedure in the East African Community: Registration Timelines and Way Forward

A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review the dossier was 391 days and the minimum time was 44 days. For applicants, the maximum time to respond to queries was 927 days and the minimum time was nine days. The total median time for granting marketing authorisation by the National Medicines Regulatory Authorities (NMRA) decreased from 174 to 39 working days in 2015 and 2019 respectively. However, not all EAC NMRA has granted marketing authorisation to all 57 products due to non-payment of applicable fees by applicants. Long regulatory approval timelines were contributed by limited capacity for timely scientific review of dossier by some NMRA, lack of online portal to share dossiersand assessment reports, delay in responding to queries by applicants and deficiencies in dossier. The metric tool and register of medical products submitted for joint scientific review had incomplete data. Challenges were identified and actions recommended to ensure regional regulatory system optimization, efficiency, transparency, sustainability and accountability.</jats:p