Pharmaceutical Regulatory Affairs: Open Access

Testing of elemental impurities as heavy metals has been in use for many years. Lack of sensitivity and reproducibility are the main limitations of current heavy metals procedure USP <231>. The procedure described for heavy metals will detect Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu and Mo. The new chapters are designed for safer limits and enhanced detection limits. ICH was proposed a draft consensus guideline and under step 2b version in the year 2013 and posted as official from December 2014 under step 4 version. EMEA released a comment by stating that new marketing authorization for new product should comply with ICH/CHMP guideline effective from June 2016; where a control of an elemental impurity is warranted, an elemental specific method is requested by the guideline. Therefore, a non-specific compendial test for heavy metals will not be accepted. USFDA published the final Q3D Elemental impurities guidance on September 2015. Color comparison of test will be replaced by instrumental techniques like Atomic absorption spectroscopy (AAS), Graphite furnace atomic absorption spectroscopy (GFAAS), Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS).

A simple, accurate, precise and robust reverse phase high performance liquid chromatographic method has been developed and subsequently validated for the simultaneous estimation of atorvastatin (AT), ezetimibe (EZ) and fenofibrate (FE) in commercial formulation. The method has shown an adequate separation for AT, EZ and FE. The drugs were resolved on an enable C-18 Column (25 mm x 4.6 mm i.d, 5 μm particle size) using Shimadzu SPD-20A prominence UV-Visible detector with the mobile phase composed of acetonitrile and phosphate buffer (pH 3.3) in the ratio of 90:10% V/V as mobile phase at a flow rate of 1 mL/min and the detection was carried out at 254 nm. The retention time of AT, EZ and FE were found to be 3.155, 5.299 and 6.215 min respectively. The linearity of the proposed method was investigated in the range of 10-100 μg/mL, 10-100 μg/mL, and 160-1600 μg/mL for AT, EZ and FE, respectively. The limit of detection (LOD) was 2.18, 0.87, and 20.9 for AT, EZ and FE, respectively. The limit of quantification (LOQ) was 6.8, 2.6 and 63.6 for AT, EZ and FE, respectively. The % RSD from the precision and accuracy studies was found to be below 2%. The proposed method was statistically evaluated and can be applied in regular quality control of AT, EZ and FE in pharmaceutical dosage forms.

Organophosphate (OP) poisoning continues to be a recurrent cause for admission to hospitals and intensive care units (ICU) in under emergent countries. OP poisoning is the most commonly prevailing up to the ratio of (27.64%) and has the highest death ratio (13.88%) of poisoning in Asia. This poisonings causes up to 25% mortality rate worldwide. In this case presentation a young girl age was sent to ICU after ingestion of OP insecticide. Where medical practitioner prescribed some irrational medications which are of veto use and also don’t follow customary protocols for treating this poisoning case, the main reason behind this miss hap would probably be the lack of pharmacist intervention in health care team. This is the major drawback of our public sector hospitals in Karachi, Pakistan. Responsiveness and right treatment protocols can trim down both mortality and morbidity rates in the city and prompt appropriate therapeutic dealings can execute better prognosis in these types of urgent situations and may decreased further impediments.

European patients may benefit from innovative medicines only at the end of a complex process with a sequence of positive decisions on different levels by different stakeholders. The decision of the industry to invest in a usually global clinical development must be followed by a European marketing authorization decision and a mostly national decision on price and reimbursement until finally patients and their physicians can make an individual treatment decision. Development strategies must consider the evolution of scientific and procedural requirements. Current trends are characterized by an enhanced cooperation of regulators and health technology assessment-bodies. The increasing availability of innovative personalized or precision medicines is reflected in the new procedural tools like European Medicines Agency’s priority medicines scheme and adaptive pathways concept. The UK decision to leave the EU will have consequences for their contribution to the European regulatory and health technology assessment network. Current strategies for the successful development of innovative medicines may need adjustments to address both scientific and political changes.

Background: Cosmeceutical regulatory and legislation framework continue to play a significant role in beauty and care companies and biotechnology establishment and market expansion worldwide. Comparably, in local high quality cosmeceutical and international brands production and marketing innovations is one of the fastest growing sectors with economic benefits in the Kingdom. This article examines cosmeceuticals market landscape and investment opportunities insights important market investment, opportunities-driven demand and emerging economy in saudization and employment growth in Saudi Arabia.

Results: Our findings showed that there is a growing need to enhance and build partnerships and collaborations in improving pharmaceuticals including cosmeceuticals investments, networks and platforms to move forward market diversification and growth in the Kingdom. Moreover, adequate and efficient harmonization and regulatory processes are vital in accelerating the current empowerment, sustainable economic and social gains and benefits including increasing saudization. Fostering comprehensive health and beauty products regulatory compliance and capacity development in existing and new products premarket approval, ingredient control and labeling warnings and marketing best practices. Notably, constant cosmetovigilance nationwide is vital for evidence-based solutions in flourishing new cosmeceutical firms and market needs and demand. Promoting import and export minimize clearance approval barriers and challenges, scaling up market openness to international competition, while ensuring consumers safety is crucial.

Conclusions: Cosmeceutical industry and market has great potential to change population perception, acceptance, uptake and utilization of beauty and personal care products. With increasing fascination among young vibrant populations including annual large Muslim pilgrims and visitors, the cosmeceuticals product market partnerships and investment technology advancements should be supported in new emergence potential strategic market ties and solutions.

Since its inception in 2004, Canadian regulation of natural health products (NHPs) has been evolving. Implementation of the novel Natural Health Products law by Health Canada, the national regulatory agency, has been responsive to both consumer desires for novel products for health care, but also potential concerns over product safety. The agency has developed numerous webpages explaining its approach to this new regulatory category, which has included regulations and guidance documents and refinement of both. Due to its many layers, the information is not very transparent. In addition, the information has been changing and is constantly under revision. For this reason, a review of the legislation, regulation and policies was embarked upon which led to the preparation of an overview of up to date information that we hope will be useful to those who plan to pursue the Canadian NHP system.

Buying drugs/medicines online is the latest trend amongst the Indian patients and consumers. With this increasing trend of buying medicines online, number of online pharmacies also increase. But there is lack of proper regulatory checks and balances for exercising regulatory control over e-pharmacies. This eventually leads to flourishing of e-pharmacies like mushrooms. There are several other factors also which fuel the gearing up of epharmacies like increased number of netizens, long term illness patients and increased chronic diseases. As we all know India is the country of youngsters and they are spending more and more time on internet through mobile or computer. Due to the advancement of technology, access of drugs through Internet is very easy for common man. Numbers of internet users in India have been increased continuously since 2000. This is the high time for the epharmacy model to grow with the drastically increasing netizens, smart phone users and patients. E-pharmacies business is growing very fast in India although its mechanism of regulation is not decided yet. The success of the model is not guaranteed in shaky and cloudy regulatory regime but its graph is going higher day by day. There is lack of proper and clear laws for e-pharmacies. The laws governing Pharmacies in India are derived from Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; Pharmacy Act, 1948; Indian Medical Act, 1956 and Code of Ethics Regulations, 2002 etc. E-pharmacies come under the purview of the Drugs and Cosmetics Act, 1940 and the Information Technology Act, 2000. But current Drugs and Cosmetics Act, 1940 doesn’t distinguish between online and offline pharmacies. It seems e-pharmacies may not abide by these regulations and bypass them. Regulatory authorities finds it difficult to control, monitor and track sell of drugs via internet as there is lack of clear guidelines in India regarding the same. E-pharmacy may be proved as dangerous trend in future if not regulated properly.

Background: Nationwide medical device registries have the potential to provide real world data for regulatory purposes. The objective of this article is to assess how to develop and manage Nationwide Registries Associated with Cardiovascular Medical Devices (NRACMD).

Methods: A questionnaire comprising of 43 items was designed to clarify the quality, characteristics, utility and sustainability of existing NRACMD in Japan. It was then sent to various organizing bodies.

Findings: Eight organizations responded to the questionnaire. Three NRACMD were device-specific registries in which the patient was registered when a device was used. The others were procedure-specific registries. Six registries covered more than 95% of target population and two covered 80-95%. Five registries were associated with specialty board certification systems or with physician qualification for using priority devices. No NRACMD was linked to medical re-imbursement. All NRACMD were used for academic purposes related to scientific papers. Two registries were currently in use for all case surveillance under the provision of the Japanese PMD-ACT. One registry provided a historical control group for a device in clinical trial for pre-market application. The analytical output was provided to participating institutions in all registries and to manufacturers in five registries. In terms of registry management sustainability, different funding sources including public funding, funding from institutions or from physicians and manufacturers were used for NRACMD. Accuracy of registered data was verified by institutional site visit and collation of extracted sample data.

Interpretation: Japan currently has eight NRACMD are in operation. Although mainly used for academic purposes, there are several examples where data have been used for regulatory purposes and shared with the manufacturers. Cooperation between the academic sector, industry and regulatory bodies is essential for efficient use of NRACMD data.