scholarly journals REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA

2018 ◽  
Vol 2 (2) ◽  
pp. 7-15
Author(s):  
Raja Mohan Reddy G. ◽  
M. P. Venkatesh ◽  
Achin J. ◽  
Pramod Kumar T.M.
Keyword(s):  
Regulatory Authority ◽  
Generic Drugs ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Pharmaceutical Market ◽  
Regulatory Requirements ◽  
Drug Products ◽  
Drug Registration ◽  
Good Market ◽  
Gain Access

Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in the Ghana are generic drugs which are considered as value for the money and affordable. With Ghana Regulatory Authority is the Food and Drugs Board, which takes decision to register the product and issues Registration Certificate. This study mainly focuses on the regulatory environment, registration process involved and the regulatory requirements that are applicable for the generic drug products in Ghana.

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.

scholarly journals REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

2018 ◽  
Vol 3 (1) ◽  
pp. 62-74
Author(s):  
Achin Jain ◽  
Venkatesh M. P. ◽  
Raja Mohan Reddy.G ◽  
Pramod Kumar T.M.
Keyword(s):  
Generic Drugs ◽  
Pharmaceutical Products ◽  
Critical Parameters ◽  
Regulatory Environment ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Registration Process ◽  
Drug Registration ◽  
Asean Countries

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.

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 Requirement and Step for Registration and Approval of Indian Drug Products in Overseas Market

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Rushikesh Aher ◽  
Pratik Aher ◽  
Tejas Ahire ◽  
Hitesh V. Shahare ◽  
Charulata T. Nemade
Keyword(s):  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Raw Material ◽  
Critical Parameters ◽  
Material Base ◽  
Technical Documentation ◽  
Regulatory Requirement ◽  
Drug Products ◽  
The World ◽  
Overseas Market

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. It has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage. India has one of the lowest manufacturing costs in the world. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for Indian companies to develop a single drug that can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. This article covers the processes involved and requirements like import-export code, technical documentation, filing and reviewing process of drug master file, certificate of pharmaceutical product, common technical document (CTD), eCTD, and ACTD, for the registration and approval of Indian drug products in the overseas market.

Recent developments in US law: Remedies and damages for improper patent listings in the FDA's Orange Book

10.5912/jcb29 ◽  
1969 ◽  
Vol 9 (3) ◽  
Author(s):  
Daniel G Brown
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Pharmaceutical Product ◽  
Pharmaceutical Companies ◽  
White House ◽  
Drug Products ◽  
The Us ◽  
Recent Developments ◽  
The Usa ◽  
Orange Book

The Drug Price Competition and Patent Term Restoration Act (Publ. No. 98-417, 98 Stat. 1585 (1984)), commonly known as the Hatch–Waxman Act (the Act) provides the statutory framework by which most generic drugs are approved for marketing in the USA. Most provisions in the Act concern the standards and procedures the US Food and Drug Administration (FDA) must follow to approve generic drugs. A relatively small number of the provisions, however, create a framework for resolving patent disputes between the brand and generic pharmaceutical companies. These provisions have been the subject of much recent activity, in the US Courts, in Congress, in the FDA itself and in the White House. Much of the activity revolves around a publication by FDA entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known colloquially as the Orange Book.Under present FDA practice, the mere listing of a patent in the Orange Book corresponding to a brand pharmaceutical product invokes a number of statutory provisions that confer valuable exclusivity rights on the brand company, and also possibly on one or more generic companies. This situation creates a strong incentive for patentees and brand pharmaceutical companies to list patents in the Orange Book. A number of recent court cases have addressed the remedies and damages available when the listing is found to be improper. Thus far, the most successful means to challenge or prevent improper listings has been through private and governmental enforcement of the antitrust laws.

scholarly journals The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union

2021 ◽  
Vol 25 (1) ◽  
pp. 32-40
Author(s):  
О.S. Popov ◽  
І.V. Kravchenko ◽  
V.Ye. Dоbrоvа ◽  
K.M. Tkachenko
Keyword(s):  
United States ◽  
European Union ◽  
Generic Drugs ◽  
Low Cost ◽  
The United States ◽  
The European Union ◽  
Regulatory Requirements ◽  
Drug Registration ◽  
Pharmaceutical Manufacturers ◽  
Mandatory Requirement

Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs. Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results. Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted. Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers. Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.

scholarly journals ДОСЛІДЖЕННЯ СТАНУ ОРГАНІЗАЦІЇ ЗАБЕЗПЕЧЕННЯ НАСЕЛЕННЯ ЛІКАРСЬКИМИ ЗАСОБАМИ В РОКИ НЕЗАЛЕЖНОСТІ УКРАЇНИ -СТАНОВЛЕННЯ ФАРМАЦЕВТИЧНОГО РИНКУ

2015 ◽  
Author(s):  
V. O. Boryshchuk ◽  
O. S. Solovyov ◽  
T. M. Krasnianska ◽  
I. V. Klymenko ◽  
S. V. Auhunas ◽  
...  
Keyword(s):  
Large Scale ◽  
Generic Drugs ◽  
Pharmaceutical Market ◽  
Small Scale ◽  
Regulatory Requirements ◽  
Drug Molecules ◽  
Market Formation ◽  
Pharmaceutical Activity ◽  
The Law ◽  
Methods Analytical

<p>The aim of the research was to study the correspondence of existing legislative and regulatory requirements of the pharmaceutical industry development, the analysis of the formation of the Ukrainian pharmaceutical market, the condition of drug assistance according to European requirements and recommendations of the WHO.</p><p>For the study archival materials, publications in scientific journals, and mass media were used, laws and provisions regulating pharmaceutical activity were studied and a survey among citizens was conducted. Systematic and logical methods, analytical and comparative analysis were applied, and own researches were performed.</p><p>For 22 years of Ukrainian statehood formation the following institutes were created: Pharmacological College, Pharmacopoeia Committee and State Service for Quality Control of Drugs which were transported to other institutes. Important laws were adopted: the Law of Ukraine «On Medicines», the Law of Ukraine «On small-scale privatization», the Law of Ukraine «On large-scale privatization» and others, which contributed to the formation and development of the pharmaceutical market.</p><p>In comparison with 1990 the amount of drugstore chains increased two and a half times and in 2013 in the country already worked 15 566 drugstores, including 3 025 in villages. Specific peculiarity of pharmaceutical market formation in Ukraine was the creation of powerful own regional and all-Ukrainian drugstore chains, that is greatly different from such situation in EU countries, where the legislation allows to have only one or two drugstores. As the result of pharmaceutical market formation the drugs nomenclature increased eight times and now makes up more than 20 000 names, including 92.4 % generic drugs. According to publications, Ukraine lacks about 40 % of drug molecules needed for medical treatment, and 30 % of studied drugs are not proved. There is the problem of uncontrollable turnover and drugs consumption in Ukraine. Self-treatment is widespread today: 82 % of Ukrainians prescribe medicines by themselves even when they feel a little unwell.</p><p>Among all examined 75 drugstores in different regions (Zakarpattya, Rivne, Khmelnytsk, Kherson etc.) people can get drugs without prescription. During 2014 the pharmaceutical market in comparison with previous year rose by 14 % and its income made up 36 billion UAH. Drug producers perform aggressive marketing and break rules of drugs advertising. Among important problems that require the improvement of legislative and regulatory base at governmental level concerning the economic drug assistance for all population groups.</p>

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

2021 ◽  
pp. 174113432110007
Author(s):  
Lovely Joylein ◽  
Bishop Adhikari ◽  
Megha Chellath Kottayi ◽  
GS Ravi ◽  
Akhilesh Dubey
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
The United States ◽  
Economic Benefits ◽  
Dosage Forms ◽  
Regulatory Requirements ◽  
Solid Dosage Forms ◽  
Drug Products ◽  
Solid Dosage ◽  
Pharmaceutical Manufacturers

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.

scholarly journals Segmentasi Pelanggan Ritel Produk Farmasi Obat Menggunakan Metode Data Mining Klasterisasi Dengan Analisis Recency Frequency Monetary (RFM) Termodifikasi

2020 ◽  
Vol 7 (3) ◽  
pp. 573
Author(s):  
Arief Wibowo ◽  
Andy Rio Handoko
Keyword(s):  
Data Mining ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Customer Segmentation ◽  
Selling Price ◽  
Data Mining Algorithm ◽  
Transaction Data ◽  
Pharmaceutical Drug ◽  
Drug Products

<p class="Abstrak">Secara umum, pembelian produk farmasi di Indonesia tidak memiliki pola. Pembelian produk farmasi seperti obat-obatan, dilakukan oleh individu bukan sebagai persiapan untuk menjaga kesehatan, namun sebagai respon terhadap penyakit yang sedang diderita. Di sisi lain, pelanggan retail produk farmasi obat biasanya dipengaruhi oleh faktor harga jual dan faktor kecocokan (sugesti) pada merk obat tertentu sewaktu melakukan pembelian. Berdasarkan kondisi itu maka pola pembelian obat bagi masyarakat Indonesia menjadi tidak dapat diprediksi. Hal tersebut membuat pelaku usaha di bisnis ritel produk farmasi obat, relatif sulit untuk meningkatkan nilai penjualan. Salah satu upaya yang bisa dilakukan pelaku bisnis untuk meningkatkan pendapatan adalah dengan melakukan promosi penjualan berdasarkan jenis kelompok pelanggannya. Transaksi pembelian produk farmasi obat dapat dianalisis untuk mengetahui segmentasi pelanggan berdasarkan pola pembelian. Riset ini telah berhasil memodelkan segmentasi pelanggan ritel apotek dengan teknik data mining klasterisasi. Metode yang digunakan adalah melakukan analisis data transaksi pembelian yang terdiri dari atribut <em>Recency Frequency Monetary (RFM)</em> termodifikasi. Analisis telah melibatkan atribut Kuantitas <em>(Quantity)</em> dari data transaksi pembelian produk farmasi obat sebagai eksperimen modifikasi model. Pada proses pemodelan klasterisasi, studi ini menggunakan algoritme data mining K-Means. Hasil penelitian menunjukkan bahwa segmentasi pelanggan yang optimal berada pada dua klaster berdasarkan hasil analisis <em>QRF (Quantity, Recency </em>dan<em> Frequency)</em> menggunakan evaluasi <em>Davies Bouldin Indeks (DBI)</em> dengan nilai 0,527. Kinerja model tersebut dibandingkan dengan algoritme <em>K-Medoids</em>. Hasil klasterisasi pelanggan pada dua kategori menggunakan K-Medoids memiliki nilai DBI sebesar 1.334. Berdasarkan nilai pembanding tersebut maka metode K-Means terbukti lebih baik dalam pembentukan klaster pelanggan ritel farmasi obat pada analisis atribut <em>Quantity, Recency </em>dan<em> Frequency.;</em></p><p class="Abstrak"><em><br /></em></p><p class="Abstrak"><em><strong>Abstract</strong></em></p><p class="Abstract"><em>In general, the purchase of pharmaceutical products in Indonesia has no pattern. The purchase of pharmaceutical products such as medicines, made by individuals not as preparation for maintaining health, but in response to the illness being suffered. On the other hand, retail customers of pharmaceutical drug products are usually influenced by selling price factors and suggestions for certain drug brands when making a purchase. Based on these conditions, the pattern of purchasing drugs for Indonesian people is unpredictable. This makes businesses in the retail business of pharmaceutical drug products, relatively difficult to increase sales value. One effort that businesses can do to increase revenue is to conduct sales promotions based on the type of customer group. Drug pharmaceutical product purchase transactions can be analyzed to determine customer segmentation based on purchase patterns. This research has successfully modeled the pharmacy retail customer segmentation with clustering data mining techniques. The method used is to analyze the purchase transaction data consisting of modified Recency Frequency Monetary (RFM) attributes. Analysis has involved the Quantity attribute (Quantity) of the transaction data of pharmaceutical drug product purchases as a model modification experiment. In the cluster modeling process, this study uses the K-Means data mining algorithm. The results showed that the optimal customer segmentation was in two clusters based on the results of the QRF (Quantity, Recency and Frequency) analysis using the Davies Bouldin Index (DBI) evaluation with a value of 0.527. The performance of the model is compared with the K-Medoids algorithm. The results of customer clustering in two categories using K-Medoids have a DBI value of 1,334. Based on these comparative values, the K-Means method is proven to be better in forming pharmaceutical drug retail customer clusters with analysis Quantity, Recency and Frequency attributes.</em></p><p class="Abstrak"><strong><em><br /></em></strong></p>

scholarly journals Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review

2018 ◽  
Vol 6 (2) ◽  
pp. 14-21
Author(s):  
Juhi Ashwinbhai Randeria ◽  
Ronak Dedania ◽  
Zarna Dedania ◽  
Vineet Jain ◽  
Meghna Danej
Keyword(s):  
Development Process ◽  
Pharmaceutical Product ◽  
Pharmaceutical Market ◽  
Approval Process ◽  
Regulatory Requirements ◽  
African Countries ◽  
Individual Country ◽  
African People ◽  
Market Authorization ◽  
Diseased Condition

Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. The objective of this study is to delve in various parameters required for registration for externally developed pharmaceutical product African countries. A dossier containing detailed information about the drug and results of the studies carried out in its development process has to be submitted to the regulating bodies for getting market authorization. CTD is critical for dossier submissions. A comparative study will help the sponsor to file the dossier in many countries simultaneously; which can save time and money. Thus knowledge of guideline specific for individual country becomes important to determine the most stringent member, which shall ease approval process in other target countries in the region.

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