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The Future of pharmacogenomics

Although pharmacogenomics has a bright future and has made important progress in recent years, it is still in its early stages. It is time to use the untapped potential of genome sequencing and related omics technologies to change the future of drug development and the management of commonly used prescription drugs.

Although no one can question the critical importance of the human genome in influencing how drugs achieve efficacy or compromise safety, relatively little work has been done to incorporate such strategies into today’s routine medical practice or new drugs. Clinical trials not only need to determine the link between genes and treatment results, but also need to confirm initial findings, clarify the meaning of these links, and translate them into prescription guidelines.

Active efforts are needed, through partnerships and collaborative efforts between the federal, academic, and private sectors, or possibly enhanced supervision, to ensure that this promising application of genomics technology is rigorously evaluated.

But for now, we’ll have to wait and see how and when pharmacogenomics will truly shape the future of the pharmacy industry.

Regulatory Scenario of Brazilian Medical Products for COVID-19

After 8 months of the pandemic, there was an impact on Brazil’s regulatory landscape for medical products supporting and treating OVID-19. It is already possible to make an analysis about the obstacles and the rules of exemption of ANVISA for the entry of Medical Products in Brazil.

The speed of ANVISA’s process analysis and prioritization were crucial to the rapid supply of medical devices to the Brazilian market, identified as a priority for use in health services, due to the international public health emergency related to SARS-CoV-2.

In an agile manner, ANVISA broke barriers and obstacles facilitating the issuance of automatic import authorizations via Siscomex, in addition to the import of products classified as notified without proper regularization by ANVISA. Products requiring Good Manufacturing Practice Certification (CBPF) and registration, had their average analysis time reduced from 1 and a half year to 72 hours. Products such as masks, gloves and respirators entered the country with great speed, in addition to having been verified a growth of the internal market directed to the national production of these products.

In order to make the analysis process transparent to all manufacturers and importers, ANVISA has created a BI – Bussines Inteligence tool which demonstrates in real time all registration requests and CBPF for VOCID tests, where it is possible to follow requests, status, deferrals, requirements and failures.

We are sure that many products of inferior quality or even without proof of effectiveness have entered Brazil in this emergency situation, but ANVISA has fulfilled an important role of acceleration, debureaucratisation and efficiency. It is now redoubling its monitoring efforts in the post market action. There are 148 precautionary measures taken so far, divided among the categories of cosmetics, health products (related), in vitro diagnostic products and disinfectants, such as: interdictions, suspension of imports, distribution, use and collection of products on the market.

Other legislation also contributed to this transit of international products and the rapid supply of the country, and the Brazilian industry itself surprised, because when the pandemic of the new coronavirus led the country to live in a state of calamity, an impact that was feared was that of shortages, whether on supermarket shelves or in the health system. Although the health and economic effects of covid-19 remain, the industry has done its part to help Brazil through this most acute period of crisis that we face. Throughout the country, the productive sector has shown solidarity and speed of response, making rapid adjustments in production lines to meet the basic needs of the population.

Finally, it is important to clarify that this flexibilization does not apply to all products and will not remain active for a long time either. The regulatory window for these adjuvant products in the treatment and diagnosis of Covid-19 should close as soon as the vaccines begin to be marketed, bringing countries out of their state of emergency and back to a new health normality.

Cannabis Legalization in Brazil

With a growing demand for regularization and availability in the Brazilian market of various products obtained from the Cannabis sativa plant and because there is not enough data to prove the safety, efficacy and quality of most of the products obtained from this plant, the National Health Surveillance Agency ( ANVISA) started to create regulatory paths to make cannabis products available in Brazil.

As Cannabis products do not fit into any of the categories provided for in Brazilian health legislation, a new regulatory category was created, where the requirements for authorization, manufacture, import, dispensation, control, among others for Cannabis products were established.

The Sanitary Authorization for Cannabis products was created in order to make available, in the quickest way to the Brazilian population, safe and quality products containing Cannabis derivatives, but which did not complete the necessary studies for registration as a medicine.

The manufacturer or importer that wishes to commercialize Cannabis products must, prior to requesting Sanitary Authorization, have municipal and federal health licenses for the activities of manufacturing or importing medications and medications subject to special control. Federal health licenses are issued by ANVISA, and are called “Authorization of Business Operation – AFE” and “Special Authorization – AE”, for drugs subject to special control. In addition, it is necessary that the national or international manufacturer company has the Certificate of Good Manufacturing Practices for medicines issued by ANVISA and that it complies with the Good Distribution and Storage Practices of medicines.

To request Sanitary Authorization of Cannabis products, technical and scientific documents must also be sent to ANVISA containing the justifications, technically based, regarding the development of the Cannabis product, in addition to other documents and information, such as the labelling and packaging model, information leaflet, stability studies, among others.

It is important to note that Cannabis products can only be approved for use orally or nasal, in forms of immediate release and that the asset consists of plant derivatives or phytopharmaceuticals. In addition, Cannabis products are not allowed to be marketed in the form of a plant drug from the Cannabis spp plant. or its parts. In addition, cosmetics, smoke, health products and food will not be considered cannabis products, regardless of their status in the country of origin, when it comes to imported products.

Finally, it is important to clarify that the rule dealing with Sanitary Authorization for Cannabis products is temporary and will be revised in 3 years, which means that companies that are interested in obtaining authorization, have until December 2022 to adapt and request the granting of this authorization.

Technology: Imperative for Life Sciences

Throughout life sciences sector a certain viewpoint towards information technology has prevailed over the years. Unfortunately, too many life sciences organisations believe that technology doesn’t give their business any competitive advantages but only the most basic capabilities and therefore, they have traditionally minimised their investment in this area while still managing to maintain an appropriate performance level.

If life science companies want to lead their sector, they must quickly adopt the latest technologies so that they can progress and develop in the modern world in which we live today. Enterprises that are keen to lead the way in the life sciences sector must have a very clear strategy for the adoption of technology to achieve optimal success in the field.

The pressure on the healthcare sector to improve and evolve is massive. Technology will be the key to unlock immense value or the barrier that holds it back. For the companies that will lead the pack in the future, the technology overhaul is already under way.

Digital transformation offers biopharma and medtech companies opportunities to execute efficiently, engage effectively, and innovate new products and services. Technology allows patients to become more engaged with the care that they receive and they expect transparency and greater convenience in the health care services they benefit from.

Digital transformation initiatives will allow life science and healthcare brands to grow customer reach, improve overall user experience and boost customer retention by establishing a greater presence in the digital market. This means building a relationship with consumers through the personalization and customization of digital channels, as well as through selling products and services both directly and in digital marketplaces. These advantages will also extend to B2B sales opportunities within the life sciences field, further enhancing the overall digital brand.

Therefore, it’s imperative that businesses are able to innovate and adapt in the ever-changing life sciences market.

Regulatory Affairs Management

Setting performance targets is an established practice for the pharmaceutical industry, enabling it to drive performance. At a time when it is common practice for medicines to be developed for a global market and companies are endeavouring to expedite the drug development process, Regulatory Authorities have also been concentrating in improving their efficiency and effectiveness. Up until now, for most authorities, this has involved only the streamlining of existing processes and resulted in marked improvements in approval times. In order for further developments to be made, authorities will have to evaluate extensively their processes.

Performance measures must reflect more than just speed. However, measuring quality is far more difficult. What systems can therefore be put in place to ensure consistency in quality across therapeutic areas within authorities and across national authorities? It is not surprising that questions are being asked as to how performance might be measured and compared between different authorities. Issues such as “what target should be set for the review of new drugs?” or “how can quality be assured?” are now considered to be of critical importance. These questions were addressed by those who are actively involved in ensuring the regulatory review system abide the authorities’ responsibilities to both the public and industry.

Dramatic changes are leading towards a different generation of pharmaceutical research and development, which will be global, outward looking and driven by technology, genetics and a variety of partnerships. Value for money will become the driver in the marketplace. However, drugs of tomorrow will be judged on their ability to increase value to the patient and the payer, both therapeutically and financially.

In such an environment, there will be a need for the skilful use of strategic targets and performance management. Not only will this generation of pharmaceutical research and development require a good understanding of underlying sciences and technologies, it will also demand a more fruitful and flexible collaboration between industry and regulators. This partnership should extend beyond very tangible business of new drug development to embrace mutual learning in the important business of defining and monitoring performance targets and learning from best practices.

Do you know how long it takes for a drug to be approved? It takes approximately seven to ten years to move a drug from compound identification to Phase I of clinical trials to approval by the FDA, so firms cannot afford to get it wrong at any step in the process. This is where strategic R&D advisors come in, empowering their customers with faster, more efficient and more profitable launches, following the rules imposed by regulation, and ensuring their growth.

While everyone understands the importance of developing new drugs, what is less well understood are the processes through which it happens. It is not enough to simply identify which roles contribute to firm success, effective strategy execution requires that managers help to consistently enable performance in specific positions and at specific times. To deliver on this master plan there are essential strategy capabilities such as product registration, sales and marketing studies, government relations, quality assurance, among others, which need to be called into action. By far, one of the most relevant organizational capability is in the domain of regulatory affairs.

Regulatory Affairs is a department in a pharmaceutical company which critical role is to ensure that its organization complies with all of the regulations and laws pertaining to product research, in order to delivery safe and effective healthcare products to individuals around the world. Their role is to develop and execute a regulatory strategy to ensure that the product is approvable by target market regulators but is also differentiated from the competition in some way, and also to ensure that company’s activities are conducted in accordance with regulations and guidelines established by regulatory authorities. The success of regulatory strategy is less dependent on regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents.

In this highly regulated environment, Regulatory Affairs play a critical role not only as the interface with health agencies and as a link between different departments in the company, but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug. They are involved in all stages of drug development, and after drug approval as well. The drug development process is a lengthy, complex and extremely costly albeit necessary process. Pharmaceutical companies use all the data accumulated during discovery and development in order to register the drug and thus market the drug. Throughout development stages, the companies have to abide by an array of strict rules and guidelines in order to ensure safety and efficacy of the drug in humans.

              Although specific challenges that regulatory professionals face vary, the phenomena that underpin have not changed over the years. Regulations change, leading to changes in regulatory guidelines; novel technologies evolve, leading to new regulatory pathways. Organizations look to regulatory professionals for more guidance and insight, so they must learn about new things quickly to successfully meet these demands. Increasing levels of globalization without concurrent regulatory harmonization also presents significant challenges.

The regulatory professional should have a mix of scientific knowledge, negotiation skills and business intelligence. But how much of it is really science, and how much of it is affairs? The answer could be simple, as suggested by EMA: ‘Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory standards and tools’. Therefore, a scientific discipline, but conducted within a legal framework.

In essence, even the most skilled regulatory scientist must work in a team of professionals with different backgrounds and knowledge to ensure a positive outcome and a scientific approach to regulatory intelligence. This, ultimately, is the key for success. This is where you should seek professional advice. Surround yourselves by a strategic advisory company with strong technical and strategic knowledge in Regulatory Affairs and Quality Assurance, duly certified in your target markets.

Differences between Pharmacovigilance Regulatory requirements in Latin America

Pharmacovigilance is defined, according to the World Health Organization (WHO), as “science and activities related to the identification, evaluation, understanding and prevention of adverse effects or any problems related to the use of medicines”.

 

WHO has a forum for member countries to join the Program for International Drug Monitoring, so that these countries can collaborate in monitoring safety and, mainly, in identifying and analyzing new safety signs. Bearing in mind the sensitivity inherent in the collection of safety signs, there are certain requirements that all countries have to fulfill in order to be integrated in this program and, also, have an administrative structure for their Pharmacovigilance activities. One of the requirements is the creation of a National Drug Monitoring Center, designated and recognized by the Ministry of Health.

 

That said, each country has to develop its own Pharmacovigilance system based on the difference in manufacturing, local practices and genetics, all of which can lead to variability in terms of the use of medicines and the profile of adverse effects. In Latin America it is worth noting the existence of a medium to high level of Pharmacovigilance standards, in relation to the international standards recognized as high surveillance.

 

These differences in the organization and levels of development in the countries necessarily imply that a single approach is not suitable for all countries but sharing best practices across regions is an asset. In this sense, in 1990, the International Conference on Harmonization (ICH) was created. ICH’s mission is to achieve the greatest harmonization, worldwide, in order to guarantee the existence of safe, effective and high-quality medicines, and that these developments are done in the most resource efficient way. To apply this mission, ICH guidelines were developed, through a scientific consensus process formed by experts in regulation and industry, from all over the world.

 

A study was carried out in a comparative format in order to analyze the government laws that regulate the activities of the companies that have products registered in Latin American (LATAM), and compare with the guidelines proposed by the ICH. The countries included in this study were Argentina, Brazil, Bolivia, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela.

 

  1. Periodic Pharmacovigilance Report:

It is mandatory to carry out this report, according to ICH, for all registered or commercialized products, however, 7 of the 18 countries analyzed, only require the existence of this report for commercialized products, another 5 require that it also be carried out for all registered products. , and the remaining 6 countries do not specify.

The safety report is one of the tools that facilitates communication between companies and regulatory agencies, in addition to the fact that these studies suggest a tool that contributes to 38% of post-MAH regulatory actions and 64% of new adverse drug reactions (RAM).

Although the importance of the continuous monitoring of the safety of medicines, big differences were identified in the reports submitted to the regulatory agencies, in these 18 LATAM countries, in topics such as definition of products that these reports must contain, language, periodicity and start date of the monitoring, report format, submission deadline. These differences lead to an increase in the difficulty of working together between the different agencies.

 

  1. Individual Report
  • ICHs suggest adopting the CIOMS-I format, but only 16% of the LATAM countries are using this format, and the rest are using local forms.
  • Of the 18 countries, only 5 have an online notification service, most of the others request via e-mail or telephone and 2 countries have the E2B system. ICHs do not specify the most correct method of submission.
  • 67% of these countries require minimum criteria for the report to be considered valid. The criteria that are in ICH are: patient, suspect product, adverse event and notifier.
  • 22% of countries mention people who may be notifiers, but ICHs do not specify this point.
  • 7 of the 18 countries specify in their legislation the type of cases that can be reported as adverse reactions.
  • 5 out of 18 countries specify that notification must be made within 24 hours after the adverse reaction, 4 within 72 hours and only 1 in 28 hours, for serious adverse reactions. The ICH suggest that adverse and unexpected reactions should be reported within a maximum of 15 days.
  • None of the countries specify in their legislation the need to notify foreign cases.

 

  1. Responsible for Pharmacovigilance

The person responsible for Pharmacovigilance is the professional officially designated by the holder of the MAH, who is responsible for the safety of pharmaceutical products for human use, marketed by the company in its country. It is necessary that this person is qualified for the position and that he / she still undergoes training for this position specifically.

83% of the countries under study refer the mandatory existence of a person responsible for Pharmacovigilance in the pharmaceutical companies, however only 33% specify that this must be a health professional.

 

  1. Search in Scientific Literature

The scientific medical literature is recognized as a valuable source of information for monitoring the safety and the benefit-risk balance of medicines, mainly in relation to the detection of safety signs or in the identification of emerging safety issues. For this reason, it is necessary, at least once a week, for those people responsible for Pharmacovigilance to review the literature of widely used databases. For the execution of this process, MAH holders must have established a standard operational procedure for monitor these scientific and medical publications in the local magazines and in the countries where your medicines are marketed. Of the identified cases, it is necessary to establish a causal relationship with the drugs, and the valid individual cases must be submitted according to the country-specific deadlines and methodologies, in accordance to its legislation.

40% of the countries under study require this search in the scientific literature, but none of the legislation mentions parameters, periodicity, strategy, selection and restriction of terms in this search in the scientific literature, necessary documentation for this procedure, description of standards, such as the date knowledge of information, analysis of duplicity and process of submitting the literature report to the Regulatory Agency.

 

  1. Self-inspection

Self-inspection aims to assess the manufacturer’s compliance with Good Manufacturing Practices (GMP) in all aspects of production and quality control. This procedure, in addition to detecting any deficiencies in the implementation of GMP, also aims to recommend corrective actions for them, and therefore, these should be carried out periodically or in special situations.

Of the countries under analysis, only 33% mention in their legislation the mandatory performance of these self-inspections.

 

  1. Signal detection

A signal is defined as a hypothesis of a risk with a drug with data and arguments that support it, derived from data or from other possible sources. The evidence of a sign is not considered conclusive, as it may vary over time as more evidences are accumulated, however, the signs may offer additional or new information about the adverse or beneficial effects of an intervention, or information about the causality between a drug and an identified adverse reaction.

Although 72% of the countries studied require the implementation of the signal detection process, many of these LATAM countries do not have this process effectively implemented.

 

  1. Risk Management Plan (RMP)

In 2005, the European Medicines Agency (EMA) introduced the RMP as a tool for planning Pharmacovigilance activities and minimizing risks for new drugs, which allowed the adoption of a more proactive approach regarding knowledge on health issues including the safety of medicines. The RMP is defined as the plan that identifies the risks associated with a drug and the methods to clarify the safety profile, as well as the tools designed to minimize the risk to individual patients during clinical practice.

78% of the countries in this study require the presentation of a RMP and only 6 of the 18 countries require a specific local format in Spanish, not being in harmony with the format of the other LATAM and European Agencies, and this lack of harmonization makes it difficult to assess the data presented and analyzed jointly by the Regulatory Agencies.

 

In conclusion, the evolution of Pharmacovigilance systems is extremely important to ensure the protection and safety of patients, and to obtain more effective systems. For the reason, it is important to share information about the safety of medicines between the different regulatory authorities and also the need for them to adopt the international standards accepted.

Regarding the regulatory authorities of LATAM countries, it is worth noting the adoption of this mentality more and more, with increased knowledge about the need to have a strong Pharmacovigilance system to ensure patient safety.

1st Summit 2019

summit_ELS_Brasil

The first Summit 2019, dedicated to the regulatory impacts and the new European Medical Device Directive, that took place on the 11th of March in São Paulo was a big success! This event organised by ELS Solutions and by Vera Rosas counted with speakers as the CEO of ELS Solutions, Dr Diogo Sousa-Martins, and Dr Mariana Camões, Regulatory and Quality Affairs Specialist also from ELS Solutions.

CPhI South East Asia

CPHI2019

From the 12th to the 14th of March, CPhI South East Asia will gather in Bangkok, Thailand, the different sectors of the region’s Pharmaceutical Industry, from ingredients to packaging. For more information on this business relationship builder event, click here: https://www.cphi.com/sea/

ELS Solutions was a finalist of CPhI Pharma Awards, Madrid, 2018, in the category “Excellence in Pharma: Contract Services and Outsourcing” due to ELSy™, an artificial intelligence-powered matchmaking app, which brings together clients and local suppliers. Indeed, ELSy™ sells time. Time for our customers to succeed!

1st Summit 2019, dedicated to the Regulatory Impacts and the new Medical Device Regulation

1º Summit 2019, dedicado aos Impactos Regulatórios e o Novo Regulamento Europeu para Dispositivos Médicos e Produtos para a Saúde

On the 11th of March, the first big event on Regulatory Affairs in Brasil in 2019 will take place in São Paulo: the 1st Summit 2019, entirely dedicated to the Regulatory Impacts and the new Medical Device Regulation. This event, organised by ELS Solutions and by Vera Rosas will host speakers as the CEO of ELS Solutions, Prof. Diogo Sousa-Martins e a Dr. Mariana Camões, Regulatory and Quality Affairs expert also at ELS Solutions.

Do not miss this current and pertinent event! Knowing in advance the regulatory contingencies in Europe so that you can adapt in time minimising the impact in your organisation. For more information, hit here »

Technology in the change of modern medicine

nanotec

We all know that today technology and medicine go hand in hand, much has been done in this area, nanotechnology is proof of that, especially in cancer treatments. Far are the days of exclusive use of methods from other generations, nanotechnology made an important progress in the fight against this dreaded disease, the one of the most prevalent throughout the world.
The use of this advanced technology in diagnostic procedures, makes us think that the future is now and much more can be done, not only in oncology, but also in other areas of medicine for the good of Humanity and Science.
ELS Solutions monitors and develops several actions in these areas, helping our customers and partners to find innovative solutions.