Comprehensive Description of Biosimilars Regulatory Framework in Brazil | Chapter 5 | Pharmaceutical Research: Recent Advances and Trends Vol. 6

Biological products, also known as biopharmaceuticals, are medications derived from biological systems and then created utilizing contemporary biotechnological techniques. These biological products are very different from traditional synthetic drugs in several important respects. They are much larger and more complex molecules with inherent diversity therefore, different manufacturers cannot produce identical biological products, even with the same type of host expression system and equivalent technologies. Thus, legal follow-on biologics manufactured and marketed after patent expiration are usually referred to as biosimilars. Brazil is the ninth-largest economy in the world, and it boasts one of the biggest and most complicated healthcare systems in the region. The Brazilian Health Regulatory Agency (ANVISA) plays a pivotal role in shaping the biosimilar landscape, balancing innovation with safety, efficacy, and accessibility. Biosimilars are required to satisfy various regulatory requirements before being permitted to enter the market in various regions. Other issues that are related to this need to be established by national authorities. These issues include interchangeability, labeling, and prescription information. The Brazilian health monitoring agency follows the fundamental criteria established by the World Health Organization for evaluating bio-similarity; nevertheless, it does not make use of the name "biosimilar." The objective of this article is to present the Brazilian biosimilar law.

 

Author (s) Details

Kethareshwara Sujatha Deeksha
Department of Pharmaceutics, Center of Excellence in Regulatory Science, JSS College of Pharmacy, Mysuru, Karnataka, India.

 

Balamuralidhara Veeranna
Department of Pharmaceutics, Center of Excellence in Regulatory Science, JSS College of Pharmacy, Mysuru, Karnataka, India.

 

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v6/1829

Disaster Risk Reduction of Mangrove Forest Destruction in East Kalimantan Province | Chapter 1 | Research Advances in Environment, Geography and Earth Science Vol. 9

The purpose of this study was to investigate the problems that occur in mangrove forest areas continuously. Such problems have been occurring for a long time, caused by the inaccuracy of previous policies and the overlapping authority and selfishness of stakeholders. A mangrove forest can be briefly defined as a type of forest that grows in tidal areas (especially on sheltered beaches, lagoons, river estuaries) that are inundated at high tide and free from inundation at low tide where the plant community is salt-tolerant. As a result of this research, the implementation of policies carried out by the East Kalimantan Provincial Government can now be said to be successful, although there are still indicators that need to be improved, such as in the resource variable. Furthermore, it was discovered that issues persisted with the previous government's administration of the Mangrove Forest region. The findings of this study suggest that the policy of private sector activity program be evaluated in conjunction with the Central Government, and that supervision be provided following planting. Provisions in sectoral laws related to natural resources, apart from those that specifically regulate environmental protection as in Law 32/2009, are regulated in various forms. The government's implementation of policy activity program does not only involve the government and the community, but also involves the private sector and non-governmental organizations (NGOs) as a form of participation in realized forest sustainability and improving the economy of communities in mangrove forest areas.

 

Author (s) Details

Hairun Jariah
University of 17 Agustus 1945 Samarinda, Jalan Ir. H. Juanda 80-Samarinda City, Province of East Kalimantan-75124, Indonesia.

 

Sukindar
University of 17 Agustus 1945 Samarinda, Jalan Ir. H. Juanda 80-Samarinda City, Province of East Kalimantan-75124, Indonesia.

 

Lisa Astria Milasari
University of 17 Agustus 1945 Samarinda, Jalan Ir. H. Juanda 80-Samarinda City, Province of East Kalimantan-75124, Indonesia.

Please see the book here:- https://doi.org/10.9734/bpi/raeges/v9/1530

Legal Perspective on Traditional & Naturopathy Regulatory Framework in Africa | Book Publisher International

This book, Legal Perspective on Traditional & Naturopathy Regulatory Framework in Africa, delves into the legislative and regulatory landscape surrounding traditional and naturopathic medicine across the African continent. As demand for alternative therapies grows, African countries face the challenge of balancing cultural traditions with the need for effective healthcare oversight. This work explores how legal frameworks, policies, and definitions for traditional and naturopathic medicine differ across Africa's five regions: Northern, Central, Southern, Eastern, and Western Africa.

 

Drawing from extensive research on health laws and policies, the book examines key regulatory aspects, including practitioner licensing, and public health safety. Southern African countries stand out with more developed regulatory structures, often recognizing naturopathy within allied health professions. In contrast, other regions largely incorporate these practices within broader public health laws or unified traditional medicine acts. These disparities impact the quality of care, patient safety, and access to naturopathic and traditional treatments across the continent.

 

This book provides a comparative analysis of existing frameworks, identifying best practices and legislative gaps that could inform future policies. By examining country-specific laws and regional trends, the book offers valuable insights for policymakers, legal practitioners, healthcare professionals, and scholars. It underscores the potential of a well-structured regulatory environment to enhance healthcare delivery, ensuring that naturopathic and traditional medicine practices support public health goals while respecting Africa’s rich cultural heritage.

 

Author (s) Details

Prof. Raphael Nyarkotey Obu
Nyarkotey University College of Holistic Medicine & Technology (NUCHMT), Ashaiman, Ghana.

 

Please see the book here:- https://doi.org/10.9734/bpi/mono/978-93-49473-54-6

Regulations on Constructing Industrial Zones and on Environment Protection | Chapter 4 | Emerging Issues in Environment, Geography and Earth Science Vol. 2

 In Hanoi, skilled are currently 70 industrial clusters (CCNs) operating, providing significantly to business-related growth and ensuring social welfare program. Hanoi has good infrastructure in conditions of traffic, electricity, water, post office, etc. The aim of the research search out present Regulations on Constructing Industrial zones and on Environment Protection.Scope of paper: Vietnam environment standard with Hanoi case study of clusters.Methodology: Authors have secondhand qualitative and examining methods, descriptive system for primary model, combination and discussion methods.Main judgment and results: Therefore, CCN can be thought-out as the focal point for implementing within linkages between commerces and services and linking manufacturing with country areas in the region and neighborhood. Therefore, CCN is the nucleus that advances regional and local socio-economic incident. Moreover, the centralized wastewater situation system must satisfy the following preservation of natural resources requirements.Originality principles: Hanoi has been invested laboriously in infrastructure incident, this is a good condition. To develop CCNs (technical clusters). CCN is the geographical aggregation of production - business establishments, arrangements related to each one in terms of production, use of foundation and limiting loud noises.

Author(s) Details:

Nguyen Trong Diep,
University of Law, Vietnam National University, Hanoi, Vietnam.

Dinh Tran Ngoc Huy,
Banking University HCMC (Ho Chi Minh City), Vietnam and International University of Japan, Japan.

Dinh Tran Ngoc Hien,
HCM University of Technology, Vietnam.

Khuat Hong Thuan,
School of Government, Sun Yat-Sen University, Guangdong, China.

Please see the link here: https://stm.bookpi.org/EIEGES-V2/article/view/12191

Protection of Environment in Industrial Zones and Clusters: A Legal Issues | Chapter 8 | Novel Perspectives of Geography, Environment and Earth Sciences Vol. 9

The purpose concerning this study is to present atmosphere protection in modern clusters and relevant permissible issues. In Article 3, Law on Environmental protection 2020 pointed Environmental protection endeavors mean activities for fear that and limit adverse impacts on the atmosphere; responding to material incidents; overcome contamination, environmental depravity, improve material quality; realistic use of natural resources, biodiversity and answer to climate change.  This paper still presents some cases of referring to practices or policies that do not negatively affect the environment pollutions, by way of which experts resolutely arrange the implementation of measures to handle breaches of the law on preservation of natural resources. It would suggest that Relevant departments and branches need to review and correct a number of appropriate laws, in the way that the Law on Sanctions of Administrative Violations, the Law on Inspection, the Law on Water Resources, the Law on Science and Technology, etc.

Author(s) Details:

Nguyen Trong Diep,
University of Law, Vietnam National University Hanoi, Vietnam.

Dinh Tran Ngoc Hien,
Ho Chi Minh Technical University, HCM City, Vietnam.

Le Ngoc Nuong,
Thai Nguyen University of Economics and Business Administration (TUEBA), Thai Nguyen, Vietnam.

Please see the link here: https://stm.bookpi.org/NPGEES-V9/article/view/11629