Abstract:
:When registering food supplements in Russia, restrictions on the labeling and consumer leaflet contents are tightly controlled by the regulatory agencies. Thus, misleading advertising is the most difficult problem with the turnover of these products if information in the commercials does not correspond to the information on indications for use that were agreed upon during state registration (or sanitary and epidemiologic control). An established procedure of voluntary certification enables additional health claims, thus expanding the information in the label and user leaflet. Voluntary certification is the evidence base for the specific characteristics of the products with regard to their efficacy represented by an independent party. This process allows the manufacturer to inform the consumer about the beneficial properties and efficacy of food supplements and enables the buyer to make an informed choice and to avoid buying counterfeit products by purchasing high-quality safe products with proven efficacy; therefore, the buyer can receive a product that is the best match for his needs and expectations. However, since the mid-2000s, several voluntary certification systems have been developed, approved, and included in the Unified Register of Voluntary Certification Systems maintained by the Federal Agency for Technical Regulation and Metrology, Rosstandart. Thus, manufacturers can choose an authority. In addition to the conventional approach to certification requirements and schemes, various outcomes of approved claims and subsequent certification maintenance are possible. The present article analyzes universal principles of voluntary certification, its legal basis, and authority-specific outcomes of the process.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Lozda Rdoi
10.1007/s43441-019-00043-zsubject
Has Abstractpub_date
2020-01-01 00:00:00pages
177-183issue
1eissn
2168-4790issn
2168-4804pii
10.1007/s43441-019-00043-zjournal_volume
54pub_type
杂志文章,评审abstract:BACKGROUND:Medical information (MI) departments across pharmaceutical companies respond to medical inquiries about a company's products to healthcare providers, payors, patients, and caregivers. Responses provided are constructed to be relevant, accurate, scientifically balanced and delivered in a timely manner. Benchm...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00137-z
更新日期:2020-11-01 00:00:00
abstract::Time progression models provide a significant advantage in developing clinical trials and can also be used to elicit comparisons among therapeutic agents. The authors performed a meta-analysis to construct a time progression model for rheumatoid arthritis (RA), an area of significant interest for pharmaceutical develo...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479013499571
更新日期:2013-11-01 00:00:00
abstract::Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices A...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479012469950
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the pre...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00244-x
更新日期:2020-11-23 00:00:00
abstract::A growing number of organizations-including pharmaceutical and biotechnology companies, foundations and associations-are routinely implementing patient advisory boards (PAB) given their high reported value for minimal relative investment. Organizations are typically implementing PABs to solicit patient voices and pers...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479017720475
更新日期:2018-07-01 00:00:00
abstract::Attention deficit hyperactivity disorder (ADHD) is the most common neurobiological disorder in children, with a prevalence of ~6-7%1,2 that has remained stable for decades2. The social and economic burden associated with patients3, families, and broader systems (healthcare/educational) is substantial, with the annual ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015599811
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Access and use of historical control data was identified as a top stakeholder concern across organizations according to results of a survey of needs and challenges related to nonclinical data conducted by the FDA/PhUSE Nonclinical Working Group in 2011. There is a perception there may be additional ways to c...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015600203
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:According to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00231-2
更新日期:2020-10-23 00:00:00
abstract:BACKGROUND:Uncertain ascertainment of events in clinical trials has been noted for decades. To correct possible bias, Clinical Endpoint Committees (CECs) have been employed as a critical element of trials to ensure consistent and high-quality endpoint evaluation, especially for cardiovascular endpoints. However, the ef...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00206-3
更新日期:2021-01-01 00:00:00
abstract::Adaptive designs are increasingly used in clinical trials. The Drug Information Association's Adaptive Design Scientific Working Group (ADSWG) works to foster collaboration among regulatory agencies, academia, and pharmaceutical and biotech companies to further the science of adaptive clinical development. The ADSWG S...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014522468
更新日期:2014-07-01 00:00:00
abstract::In a global environment where health care costs are soaring, R&D efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations such as adaptive trial designs, real-world data collection, precisi...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018814224
更新日期:2019-05-01 00:00:00
abstract::The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulat...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018791539
更新日期:2019-07-01 00:00:00
abstract:OBJECTIVE:To identify, evaluate, and characterize the variety, quality, and intent of the health economics and outcomes research studies being conducted in SAARC (South Asian Association for Regional Cooperation) nations. METHODS:Studies published in English language between 1990 and 2015 were retrieved from Medline d...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1177/2168479017731583
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND:Timely access to new medicines may be addressed through strengthening of registration efficiencies and timelines by establishing and refining value-added registration processes, resources, and systems. The aims of this study were to evaluate the timelines of the milestones of the South African review process...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00013-5
更新日期:2020-07-01 00:00:00
abstract::Quality and safety tests are required for regulatory approval of drugs and pharmaceuticals in the country to guarantee minimum safety standards, and most of these tests include animal usage. In the case of biological medicines, these safety and quality tests have to be performed on a batch-to-batch basis and require a...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015572371
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Several articles showed that statistical efficiency of multi-arm randomized clinical trials (RCTs) is much better than conventional two-arm RCTs. Multi-arm RCTs attract interest mainly when the experimental treatment regimen is not optimized or several pipelines under development exist. Breast cancer is a po...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00141-3
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:Package leaflets of medicines distributed within the European Union should use the template headings and standard texts created by the Working Group on the Quality Review of Documents (QRD). The following study investigated how the QRD template is implemented in this patient information. METHODS:All English...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015620247
更新日期:2016-01-01 00:00:00
abstract::Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval a...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015578154
更新日期:2015-05-01 00:00:00
abstract:BACKGROUND:In the breakthrough therapy designation (BTD) and Sakigake designation programs, rolling submission and close communication between applicants and regulatory authorities enable the timely access of patients to innovative medicines. However, challenges in the quality development, including chemistry, manufact...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00019-z
更新日期:2020-07-01 00:00:00
abstract::Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effec...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014558273
更新日期:2015-03-01 00:00:00
abstract::In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regul...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-019-00055-9
更新日期:2020-03-01 00:00:00
abstract::In March 2017, the US FDA introduced the new Regenerative Medicine Advanced Therapy (RMAT) designation thus recognizing the enormous potential of these medicines and the need for efficient regulatory tools to accelerate their development and their commercial availability. The development of regenerative medicines is v...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018779373
更新日期:2019-05-01 00:00:00
abstract::The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section. ...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018793130
更新日期:2019-03-29 00:00:00
abstract::Although much information is already available publically from information-sharing initiatives such as ClinicalTrials.gov, information about clinical programs is unstructured, inconsistent, and incomplete. Clinical research within bioscience companies, health care, academia, and governmental agencies could benefit fro...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479014539158
更新日期:2015-01-01 00:00:00
abstract::Social media presents new challenges to the biopharmaceutical industry for conducting pharmacovigilance activities. The authors reviewed worldwide regulatory guidance documents related to monitoring of adverse events posted on social media sites and identified gaps in current regulatory definitions for pharmacovigilan...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015587362
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:The human papillomavirus (HPV) vaccine coverage is very low in Japan since the government suspended the active encouragement of the vaccination. We aimed to conduct a benefit-risk assessment of HPV vaccination and explore different consequent scenarios to identify potential improvements to the current Japane...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1007/s43441-020-00189-1
更新日期:2021-01-01 00:00:00
abstract::The volume and diversity of data collected to support each clinical study has increased dramatically in response to the rising scope and complexity of global drug development programs. The Tufts Center for the Study of Drug Development conducted an online survey of 257 unique global companies-77% drug development spon...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018769292
更新日期:2019-01-01 00:00:00
abstract::The regulatory agencies all over the world have defined the pathway and regulations for the approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for the approval of biosimilars. In this view, there are no defined regulations for the approval of co...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章,评审
doi:10.1007/s43441-020-00114-6
更新日期:2020-09-01 00:00:00
abstract::Data quality is critical for clinical trials to obtain robust conclusions about drug safety and efficacy evaluation. Effective data quality evaluation has been one of the major obstacles to new drug approvals in China, which hinders innovation in drug discovery and development ultimately. To improve the data quality s...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479018778528
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND:Several regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the regulatory agencies to minimize the potential for bias. This becomes especially critical when assessments are not based on measurable data but are derived from the interpr...
journal_title:Therapeutic innovation & regulatory science
pub_type: 杂志文章
doi:10.1177/2168479015580382
更新日期:2015-11-01 00:00:00