Risk assessment and exemption approval procedure for the semi-closed seas according to the International Convention for the Control and Management of Ships’ Ballast Water and Sediments, 2004

The paper analyses statutory foundations applicable to ships requiring to be exempted from the mandatory installation of the ballast water management system. In particular, it deals with ships sailing on regular international lines but within the semi-closed seas, such as the Adriatic Sea. The legal framework is set out in the International Convention for the Control and Management of Ships’ Ballast Water and Sediments (BWM, 2004), the IMO Guidelines for Risk Assessment A-4 (G7), and the Croatian Ordinance on Ballast Water Control and Management, 2012 [Pravilnik o upravljanju i nadzoru balastnih voda]. The paper presents the model procedure to be followed by main stakeholders, mainly national maritime administrations and shipping companies. The paper outlines the main advantages and disadvantages of the whole process and analyses several cases of good practice. Furthermore, the main stakeholders in the approval procedure and their responsibilities are described, available risk assessment models are analysed, with the particular emphasis on the species-specific risk assessment method as the most preferred method. Finally, the need for cooperation between the involved states and their maritime administrations is considered. It is concluded that bilateral and regional cooperations are an essential element in preserving the marine environment of any sea area. In that respect, the proposed model of the BWM system exemption approval in closed and semi-closed seas, such as the Adriatic Sea, is essential for shipping companies connecting ports in different countries on regular routes. Although demanding in respect of efforts and time, a procedure is viable and may be carried out in due time and with satisfactory outcomes.

Closure of German Hard Coal Mines: Effects and Legal Aspects of Mine Flooding

Following the closure of the last hard coal mines in Germany, pumping is no longer necessary. However, the resulting rise of mine water can affect the environment. Laws have been enacted at the European and national level to protect properties. Within the framework of the approval procedure, it must be determined whether the cessation of pumping may cause unacceptable effects, including water pollution. With regard to water protection, the European Union has issued the Water Framework and Groundwater Directives, which have been implemented into German national law. These contain the prohibition of deterioration and the requirement for improvement, with the aim of maintaining or achieving good ecological and chemical status. However, before the target mine water level is reached, the water does not need to comply, since although the pumps are switched off, no mine water is being discharged. This also rules out permit requirements, which only go into effect when the target mine water level has been reached and mine water is discharging. Obviously, however, detailed planning before then is necessary.

RE-APPRAISING LAND DEVELOPMENT APPROVAL PROCEDURE THROUGH SURRENDER AND RE-ALIENATION MECHANISM IN JOHOR

The surrender and re-alienation or ‘serah balik kurnia semula’ (SBKS) mechanism in Johor has remained essentially significant for the state authority income. On account of the delay issues that impacted processing agencies and related stakeholders particularly state authority, the purpose of this article is to study the process and procedure conducted by Pejabat Tanah Johor Bahru (PTJB) in processing SBKS applications through (i) Identifying issues and challenges of existing processes and procedures that prevent the application of approval to be done in a timely manner; and (ii) To propose recommendation towards simplification and time-saving approval processes and procedures of surrender and re-alienation applications. From the analysis, there were 11 delay issues found to complete the 20 steps of the process. Thus, recommendations of approval were suggested by approval agencies and related stakeholders conducted in several series of Focus Group Discussion (FGD) as efforts to mitigate the delay issues faced by both sectors and hence accelerate the development process and generate state authority income effectively.

COMPARISON OF LAND-BASED TEST SETUPS FOR A BALLAST WATER MANAGEMENT SYSTEM

Two land-based setups were tested at different locations using the same combined treatment technologies, to assess the effect of different control and treated tanks condition as well as overall effectiveness of a ballast water treatment system. The test procedure included a five day storage period of organisms in the control and treated tanks as specifically advised in the type approval procedure for shipboard and land-based tests described in the IMO Guideline ‘G8’. The configurations and materials of control and treated tanks used in each test location were different resulting in invalid test results at one testing location.

Test algorithm to confirm the type of modern measuring devices for low absolute pressures and vacuum

The article provides information on the normative documentation applicable in the Russian Federation on the approval procedure of measuring devices, explains the procedure for carrying out tests for approval of the type of vacuum measuring devices at D. I. Mendeleyev Institute for Metrology VNIIM, summarized information about modern high-precision thermal (measuring range (1⋅10-2… 1.08⋅105) Pa, maximum permissible error of a measuring ±(10…50) %) and ionization (specified measuring range (1⋅10-7…1.3) Pa, maximum permissible error of a measuring ±(20…50) %) of vacuum gauges that have been tested for type approval since 2016. The information on the vacuum gauges contained in this article was published in the Federal Information Fund for Ensuring the Uniformity of Measurements.

Analyzing International Non-Financial Reporting Standards: Principal trends and applicability in aviation

Subject. The article focuses on the current trends in the development of non-financial reporting in the Russian Federation and worldwide. Objectives. We analyze international non-financial reporting standards on sustainable development, and provide our recommendations on the improvement of integrated reporting of the company operating in the Russian aviation industry – Aeroflot Russian Airlines. Methods. The study draws upon general methods, such as the analysis, synthesis, analogy, deduction and induction. Results. Having examined development trends in non-financial reporting and reporting standards, sustainable development reports of foreign aviation leaders, and drawbacks, we suggested how the integrated report of Aeroflot should be improved. Conclusions. In the current circumstances, businesses try to disclose predominantly positive aspects of their sustainable development activities in order to create the positive publicity. As the analysis of the Russian aviation giant’s reports show, the company provides incomplete information and misses the external approval procedure. Sourced from the analyzable standards and foreign companies’ practices, the proposed indicators will help make reporting more unbiased.

China’s New Foreign Investment Law and Its Contribution Towards the Country’s Development Goals

This article analyses China’s new foreign investment legal regime and assesses its contribution to the country’s development goals. Fulfilment of the goals entails an increase in ‘good’ investment flows and more effective regulation and management thereof. This article finds that the reform makes some positive progress towards the development goals. First, administrative control over foreign investments is eased, since a less burdensome report mechanism is established, while foreign investments not included on negative lists are exempt from the approval procedure. Second, a new system is established to strengthen post-entry supervision of foreign investments. Third, equal treatment of foreign investments as well as investment promotion and protection are strengthened. Fourth, the rules have become clearer and more transparent. However, due to certain regulatory flaws, problematic implementation, and a lack of ambition, the progress may be slower than intended. Therefore, the recent reform is only an incremental step towards China’s development goals.

FAST TRACK USA REGULATORY APPROVAL FOR DRUGS TO TREAT EMERGING INFECTIOUS DISEASES

The Food and Drug Administration has established fast track approval to speed the designation of drugs that efficiently treat serious conditions, in particular those that provide improved advantages over available therapy. Fast track designation was initiated to curtail the time period in the new drug approval procedure and to promote the drug discovery and commercialization of drug products for critical and life-threatening illness and expedite the approval of drug products demonstrating advanced efficacy toward the prevailing one. Single Phase II study is reviewed before approving the drug within fast track designation. This review article highlights the consequences, criteria for fast track designation, fast track designation process, and the timeline for fast track approval.

Regulatory Approval process for marketing drug in Japan

For the development of new drug, it requires a greater amount of research work in chemistry, Manufacturing, control, Preclinical and clinical trials. The drug approval process in all regulatory market carrying responsibilities on multiple factors such as data, safety, efficacy to public health in a country. Current constrain of affairs reveals diverse countries need to follow different regulatory requirements for Regulatory approval process for marketing drug in the different regulatory market of the country to ensure safety and efficacy of the product. In order to conduct a regulatory process for approval of a drug, every country has their unique regulation, guidelines, legislation and respective regulatory authority. Japan has its own regulatory authority for drug and medical device called the Ministry of Health, Labour, and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), respectively. In the Japan Ministry of Health, Labour, and Welfare are overseeing the approval procedure of New drug, Generic Drug and Orphan Drug also. In that regard, the Drug Approval process followed in Japan ensures that every company has adhered to specific guideline available in their respective website. The drug comes to market with safety, efficacy to enhance the health of people in Japan by scrutinised process. It results into the longevity of human, which is so apparent in their demographic chart of Japan's Population.