scholarly journals Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

Pharmaceutics ◽  
2014 ◽  
Vol 6 (2) ◽  
pp. 195-219 ◽  
Author(s):  
Sabrina Trows ◽  
Klaus Wuchner ◽  
Rene Spycher ◽  
Hartwig Steckel
Keyword(s):  
Regulatory Requirements ◽  
Drug Products ◽  
Nasal Drug Products ◽  
The U.S

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals FACTS ON DRUG REGULATIONS

2018 ◽  
Vol 2 (3) ◽  
pp. 43-47
Author(s):  
Rajkumar Gupta
Keyword(s):  
Life Cycle ◽  
Drug Regulation ◽  
Pharmaceutical Products ◽  
Regulatory Requirements ◽  
Ministry Of Health ◽  
Drug Products ◽  
Drug Regulations ◽  
The Law ◽  
Basic Facts

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.

scholarly journals REGULATORY REQUIREMENTS FOR DRUG PRODUCTS REGISTRATION IN SOUTH AFRICA

2018 ◽  
Vol 3 (4) ◽  
pp. 1-8
Author(s):  
Senthil V. ◽  
L. Srianitha ◽  
R. Baviyapriyadharshini
Keyword(s):  
South Africa ◽  
South African ◽  
Pharmaceutical Market ◽  
Regulatory Body ◽  
Regulatory Requirements ◽  
Drug Products ◽  
Drug Registration ◽  
African Health ◽  
Regulatory Submissions ◽  
South African Health

The South African Pharmaceutical market is one of the emerging markets in the world and it is important to study on how to register a drug in the promising pharmaceutical market in Africa. The MCC is the regulatory body which deals with the quality, safety and efficacy of the medicines in South African market which regulates by approving the medicines by very specific process which is unique to South African health system. They have a specific type of CTD for Regulatory submissions which is generally well known as ZA CTD. This article provides the insight on the Drug Registration process in South Africa, the details of data to be submitted to the agency and the pathways of registration an applicant can avail, categories a drug can be registered by MCC, Application fees to be paid to the agency on various types of applications are also dealt.

Composite Sleeve Repair in the North American Regulatory Environment

2020 ◽  
Author(s):  
Xavier Ortiz ◽  
Dan Jungwirth ◽  
Yashar Behnamian ◽  
Hossein Jiryaei Sharahi
Keyword(s):  
Maximum Stress ◽  
Oil And Gas ◽  
Hazardous Materials ◽  
Regulatory Environment ◽  
Department Of Transportation ◽  
Regulatory Requirements ◽  
The North ◽  
Industry Standards ◽  
American Society ◽  
The U.S

Abstract Composite sleeve repairs have been used in the pipeline industry for the last 25+ years. Fiberglass sleeves (e.g., Clock Spring®) were initially introduced in the market and are still being used as a proven pipeline repair method. For the last 15+ years, new composite materials have been introduced in the industry to provide a wider variety of repair options depending on the type of imperfections being repaired. Regulations in the U.S.A. and Canada share some requirements regarding design, installation, testing, and assessment of composite sleeve repairs. The U.S. Department of Transportation (DOT) through the Pipeline and Hazardous Materials Safety Administration (PHMSA) recommends the use of repair methods consistent with industry standards. The 2019 version of the Canadian CSA Z662 Oil and Gas Pipeline Standard includes requirements for testing and qualification according to the American Society of Mechanical Engineers (ASME) regulation PCC-2 or ISO/TS 24817, and requirements for conducting an engineering assessment to determine the subsequent maximum stress on the pipe sleeve. This paper compares the regulatory requirements for pipeline composite sleeve repairs in the U.S.A. and Canada; it describes some of the options for composite sleeve repair, and reviews engineering assessments of methodologies for composite sleeve repair.

scholarly journals The Orphan Drug Act: An Appropriate Approval Pathway for Treatments of Rare Diseases?

2019 ◽  
Vol 54 (5) ◽  
pp. 283-284 ◽  
Author(s):  
Michael Gabay
Keyword(s):  
Orphan Drug ◽  
Rare Diseases ◽  
Financial Incentives ◽  
Annual Number ◽  
Recent Past ◽  
Regulatory Requirements ◽  
Drug Products ◽  
Orphan Drug Act ◽  
Pharmaceutical Manufacturers ◽  
Financial Benefits

The Orphan Drug Act provides financial incentives to pharmaceutical manufacturers to develop treatments for rare diseases affecting limited patient populations. Since passage of the Act in 1983, the U.S. Food and Drug Administration (FDA) has approved more than 600 orphan drug indications from greater than 450 distinct drug products. The annual number of orphan drug designation approvals has increased significantly in the recent past with much of this increase driven by approval of secondary indications for previously approved treatments. This recent increase has led to concerns regarding the Act as some pharmaceutical manufacturers have reaped outsized financial benefits while avoiding the regulatory requirements and costs associated with nonorphan drug development.

Incidence of Salmonella on Beef Carcasses Relating to the U.S. Meat and Poultry Inspection Regulations

1999 ◽  
Vol 62 (5) ◽  
pp. 467-473 ◽  
Author(s):  
JOHN N. SOFOS ◽  
SHERRI L. KOCHEVAR ◽  
J. O. REAGAN ◽  
GARY C. SMITH
Keyword(s):  
Correlation Coefficients ◽  
Total Coliform ◽  
Dry Season ◽  
Wet Season ◽  
Regulatory Requirements ◽  
E Coli ◽  
Beef Carcasses ◽  
Plate Counts ◽  
Dry Seasons ◽  
The U.S

This article is part of a major study designed to collect baseline contamination data by sampling beef carcasses in seven slaughtering plants (four steer–heifer and three cow–bull plants) during both a dry season (November to January) and a wet season (May to June). Samples (n = 30) were excised from each of three carcass anatomical sites (brisket, flank, and rump) at each of three points in the slaughtering chain (pre-evisceration, following final carcass washing, after 24-h carcass chilling). A total of 3,780 samples (100 cm2 each) were analyzed for presence of Salmonella; aerobic plate counts, total coliform counts, and Escherichia coli counts were also made. After 24-h chilling, average incidence (expressed as a percentage) of Salmonella in the brisket, flank, and rump samples, respectively, for steer–heifer carcasses was 0.8 ± 1.7, 0, and 2.5 ± 5.0 for the wet season and 0.8 ± 1.7, 0, and 0 for the dry season; the corresponding percentages for cow–bull carcasses were 4.4 ± 2.0, 2.2 ± 3.9, and 1.1 ± 1.9 for the wet season and 2.2 ± 3.9, 1.1 ± 1.9, and 0 for the dry season. Depending on plant and season, ranges of probabilities of chilled steer–heifer carcasses passing the U.S. regulatory requirements for Salmonella contamination were 0.24 to 1.0 for the brisket, 1.0 for the flank, and 0.002 to 1.0 for the rump; the corresponding ranges for the chilled cow–bull carcasses were 0.25 to 1.0, 0.25 to 1.0, and 0.70 to 1.0. When the number of positive brisket, flank, and rump samples were combined, the probabilities of passing the regulatory requirements were 0.242 to 1.0 and 0.772 to 1.0 for the wet and dry seasons, respectively, in steer–heifer plants and 0.368 to 0.974 and 0.865 to 1.0 in cow–bull plants. Correlation coefficients of aerobic plate counts, total coliform counts, and E. coli counts with Salmonella incidence were higher (P ≤ 0.05) for cow–bull samples that had increased incidence of the pathogen when compared to steer–heifer samples.

Higher Yield and Quality through Particle Identification

2008 ◽  
Vol 51 (2) ◽  
pp. 55-65
Author(s):  
O. Valet ◽  
M. Lankers
Keyword(s):  
Rapid Determination ◽  
Particle Identification ◽  
Manufacturing Processes ◽  
Data Sets ◽  
Drug Products ◽  
Particulate Contamination ◽  
Yield And Quality ◽  
Analytical Result ◽  
Nasal Drug Products

The sources of particulate contamination are often not easy to identify. To control manufacturing processes, the measurement of particle concentration and size is necessary and has been routinely performed for many years. Technology has been developed to increase the information available for the immediate evaluation of particles. The method analyzes airborne particles or particles isolated from liquids automatically according to their number, size, and chemical composition.1,2 The analysis of thousands of particles enables users to locate the major sources of contamination in various manufacturing processes. The analytical tool provides rapid determination of particulate contamination, thus allowing for a quick, efficient response. Over time, the ability to compare analytical result data sets assists in detecting trends and implementing the appropriate quality management. Routine use of the technology contributes to ongoing supervision and optimization of production processes. This study reports on the use of the technology to analyze foreign particles associated with oral, inhalable, and nasal drug products (OINDP), parenterals, and coronary stents. Applications for troubleshooting and identifying latent contamination sources are discussed through several examples.

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