China
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Decontextualised Chinese medicines
Published in Vivienne Lo, Michael Stanley-Baker, Dolly Yang, Routledge Handbook of Chinese Medicine, 2022
Michael Heinrich, Ka Yui Kum, Ruyu Yao
With the inauguration of a joint Chinese-European Working Group in 2005, TCM drugs have been included in the European Pharmacopoeia (PhEur). A pharmacopoeia provides legally binding standards on the basis of a regulation of the Council of Europe Convention on the Elaboration of a European Pharmacopoeia (1964, Strasbourg, France) with the first edition having been published in 1969. Currently, 39 countries are members, with the standards also being applied in over 120 countries. The aim of including monographs on TCM drugs has been to provide modern quality standards according to the PhEur principles facilitating the use of preparations of these drugs by practitioners for individual patients. The quality standards provide a basis for safe use (Wang and Franz 2015; Fitzgerald et al. 2020), but are not a way to obtain an authorisation to market the products. As of Sept. 2020, the Commission for the European Pharmacopoeia has adopted 73 monographs of TCM substances with 32 being under development (R. Bauer, Graz, AT, pers. Com 07/2020; Council of Europe 2021). Currently, many of these botanical drugs are in fact of a very limited importance on the market, since there are no or very few products containing them on the market.
Quality by Design for Nanocarriers
Published in Carla Vitorino, Andreia Jorge, Alberto Pais, Nanoparticles for Brain Drug Delivery, 2021
Branca M. A. Silva, Cláudia Silva
The CQAs are chemical, physical or microbiological properties of the drug product which must be within an appropriate limit or range to ensure the desired product quality [9]. The CQAs identification is based on the QTPP; which CQAs impact safety and efficacy (impurities profile, mean particle size), drug product performance (morphology, in vitro drug release, leakage) and drug product manufacturability (uniformity of dosage units, viscosity) should be determined. For conventional dosage forms there is a strong understanding of how product attributes correlate with the safety, efficacy, performance and manufacturing. Yet, for new technologies such as the ones available to obtain nanocarriers, there is a need to establish these correlations, especially the in vivo performance. This knowledge should be established in a systematic way, at an early stage of development, and should include less obvious attributes (e.g. residual solvents, extractables, leachables, container closure system, impurities profile). In Table 11.2 are listed commonly identified CQAs as well as others which are product specific and often omitted. The consultation of the general chapters/monographs on specific drug products of the European Pharmacopeia (EP) and the United States Pharmacopeia (USP) are recommended. For example, the general Chapter 5 of the USP provides information about the quality tests which should be performed for inhalation and nasal drug products, while the general Chapter 1 refers to injections and implanted drug products.
Manufacturing pollen and fungal extracts
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2020
Robert E. Esch, Rosa Codina, Fernando Pineda, Ricardo Palacios
Because pollen and fungal raw materials are utilized to manufacture medicinal products for animal use, they are considered active pharmaceutical ingredients (APIs). APIs that are produced by chemical synthesis, extraction or recovery from natural products, cell culture or fermentation, recombinant DNA technology, or any combination of these processes are regulated by the U.S. Food and Drug Administration (FDA) and the Center for Biologics Evaluations and Research (CBER) in the United States [10]. The main regulatory agencies in Europe include the European Medicines Agency (EMA) in compliance with the European Pharmacopoeia (EP) [11,12], although other entities operate in particular countries.
Pharmacopeial Standards for the Quality Control of Botanical Dietary Supplements in the United States
Published in Journal of Dietary Supplements, 2023
Nandakumara Sarma, Roy Upton, Ulrich Rose, De-an Guo, Robin Marles, Ikhlas Khan, Gabriel Giancaspro
The European Pharmacopeia (Ph. Eur.) provides quality standards for the manufacture and control of medicines in Europe and in other countries that utilize Ph. Eur. These quality standards – currently more than 2,500 monographs and about 370 general texts – cover mostly active pharmaceutical ingredients (APIs) and excipients in their original state and also in the form of pharmaceutical preparations. These quality standards are legally binding for the 40 signatory parties to the Council of Europe’s Convention on the elaboration of a European Pharmacopeia (Convention on the Elaboration of a European Pharmacopeia, 1964), i.e. 39 Council of Europe member states and the European Union (EU). These monographs and general chapters are not “cast in stone,” but are routinely updated to reflect the state of the art. In Europe, pharmacopeial standards for herbals mainly provide quality specifications for medicinal products that are regulated as traditional medicines pursuant to the EU traditional medicines document, Directive 2001/83/EC, established in 2004, not for dietary supplements.
Orally disintegrating tablet containing carbamazepine and levetiracetam: formulation and in vitro and in vivo characterization
Published in Drug Development and Industrial Pharmacy, 2021
Busra Kandilli, Afife Busra Ugur Kaplan, Meltem Cetin, Numan Taspınar, Sidika Genc, Yesim Yeni, Muhammed Sait Ertugrul, Ismail Cagri Aydin, Ahmet Hacimuftuoglu
In the European Pharmacopoeia 8th ed., it is reported that ODTs disperse readily within 3 min in the mouth before being swallowed [23]. The values of disintegration time of CBZ + LEV-L-ODT and CBZ + LEV-DC-ODTs in distilled water were 1.55 ± 0.344 s and 31.50 ± 7.477 s, respectively (Table 4) and the results comply with the EP 8.0 [23]. CBZ + LEV-L-ODTs were disintegrated in a shorter time than CBZ + LEV-DC-ODTs (p<.05). As the porous structure of CBZ + LEV-L-ODT is higher than that of CBZ + LEV-DC-ODTs, the disintegration medium readily penetrates the inner surface of the L-ODTs and thus disintegration occurs in a shorter time [36,60]. In addition, the dispersion times of CBZ + LEV-L-ODT and CBZ + LEV-DC-ODTs formulations in distilled water were found to be 7.92 ± 1.569 s and 9.67 ± 2.015 s, and their dispersion times in simulated saliva fluid were 15.68 ± 1.822 s and 31.83 ± 4.561 s, respectively (Table 4).
Reliance: a smarter way of regulating medical products - The IPRP survey
Published in Expert Review of Clinical Pharmacology, 2021
Petra Doerr, Marie Valentin, Nobumasa Nakashima, Nick Orphanos, Gustavo Santos, Georgios Balkamos, Agnes Saint-Raymond
Most respondents refer to reliance approaches and mutual recognition agreements in place for GMP inspections and the role of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). A few respondents referred to the use of European Pharmacopoeia Certificate of Suitability for the quality assessment of medicines. Two respondents refer to effective reliance systems in place to speed up clinical trial authorizations (ANVISA, Brazil, and TFDA, Chinese Taipei). Interestingly, one regulator referred to the use of international regulatory guidelines for areas where the country’s own specific guidance has not yet been developed for industry.