Counterfeiting, theft, diversion and false returns to manufacturers are few of the problems faced by the pharmaceutical industry across the globe. According to the World Health Organization (WHO), counterfeit drugs make up 1% of the supply in developed countries (including millions of prescriptions in the US alone) and 30-40% in developing countries. By implementing product serialization, counterfeiting by organized crime can be considerably reduced according to pharmaceutical companies and governments of countries across the globe.

It refers to the allocation and placement of unique markings on a primary package. The markings can be a two-dimensional or RSS bar code, a human readable letter/number code or unique serialized codes that can be written onto a radio-frequency identification (RFID) tag/label. Variable data printers or preprinted labels or cartons are employed to position unique codes on each package which are then read by a vision system. Furthermore, the unique codes are uploaded to an event repository database which can be accessed by various parties, including pharmacists, law enforcement officials and even consumers, once the product is shipped and sold.

The individual packages will have unique codes which can be grouped/electronically linked to a shipping case and even to a pallet and other levels of packaging which in turn creates a child/parent/ grandparent relationship. As a result of the grouping, if the bar code on a pallet is scanned at a warehouse, the brand owner or trading partner will have tracking information regarding all shipping containers and primary containers at that warehouse. In addition, once an ePedigree law comes into action, serialization and aggregation will help to track-and-trace products from the point of packaging to the pharmacy or healthcare facility.

CURRENT SITUATION:

Serialization requirements are in heterogeneous stages of development in the US, Canada, EU and in its member nations as well as in Turkey, India, China, Brazil, Argentina and South Korea. Despite the variations found in countries laws, each nation’s regulations tend to be built around GS1 standards and are quite similar. Although the GS1 format is the most desirable standard, International Organization for Standardization (ISO), Internet Engineering Task Force (IETF) and other competing standards also apply to serialization. All activities related to drug serialization that are evolving in different countries are backed up by the overarching global initiative conducted on the World Health Organization (WHO) level. The WHO set up the International Medical Products Anti- Counterfeiting Taskforce (IMPACT).

Drug Supply Chain Security Act (DSCSA) Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information, released by FDA on 28 November 2014, is meant to address: How information is exchanged between entities within the pharmaceutical supply chain.

DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers was released on 8 December 2014 and explains how wholesalers and third-party logistics providers (3PLs) should report DSCSA information to FDA on an annual basis. Argentina legislation is effective but limited to certain products; however the number of products falling under this legislation is rapidly growing.

In January 2014, ANMAT has published a detailed specification of the central Argentina database (trazabilidat) in Spanish. In December, Brazil published RDC 54/2013, specifying track and trace requirements, accordingly manufacturers must provide serialization and tracking data for three batches of products by 10 December 2015. All pharmaceuticals must be serialized and tracked by 10 December 2016. For a growing market, that’s a critical milestone. On 23 January 2014, the first public hearing discussing implementation was held. Plenty of other countries are preparing for legislation Saudi Arabia by March 2016, Jordan and Ukraine by 2017 including Columbia and Mexico.

POSSIBLE STUMBLING BLOCKS IN IMPLEMENTATION

BENEFITS:

The leading companies are demanding solutions that will not only please legislative mandates, but also help them in achieving business benefits beyond compliance. These benefits come from the compact product control that serialization provides. They include:

• Superior product authentication and integrity, which will protect and enhance the company’s
• brands and shareholder value
• Pronounced revenue share by reducing the “gray market” activity that occurs when products are
• counterfeited and diverted.
• Finer control over and visibility into the supply chains, leading to accurate shipments.
• Fast and efficient reverse logistics or recall processes.
• Serialization also provides huge benefits for clinical trials as they can be conducted, reported and analyzed more efficiently if each of the unit doses being taken in the trial are serialized
• The healthcare industry can benefit from serialization of medical devices as well
• Link between the brand owner and the consumer can be used for creative brand loyalty programs
• (as marketing tool)
• Companies, in countries with single-payer or other centralized health care systems, reap additional
• benefits through improved ability to recoup payment from centralized government agencies that reimburse patients drug costs

In order to meet the legislative mandates for serialization, pharmaceutical companies must start planning now. Most of the governments have been extending compliance deadlines, but leading pharmaceutical companies have already started to pivot on implementing a serialization strategy and defining their requirements on trusted partners with production line serialization solutions. The “wait and see” approach by pharmaceutical companies is not the right way as all pharmaceutical companies will be impacted by serialization regulations.In the future, every pack of drug will be expected to have a unique identifier before going to the market and the industry must make amends to adjust to the changes.

The drugs manufacturing and marketing is regulated by stringent regulations, based on which companies need to submit an application to the regulatory authority for approval.Australia has been accepting paper and non-eCTD Electronic Submissions (NeeS) format of applications. NeeS, is an electronic application however it is way behind the modern type of application, which is implemented in many other parts of the globe, namely eCTD.  Australia is now moving forward in an effort to go ahead and implement the eCTD format. In the recent past, Australia has inked an agreement with an eCTD software vendor to receive, review and process electronic (eCTD) applications for the entry of prescription medicines and other therapeutic products on to the ARTG. The nation is working closely with the stake holders and plans to implement this modern format for application by the end of 2014.

Regulators at Therapeutic Goods Administration (TGA), will now take a breather owing to this change in the process, however pharmaceutical companies will face a big challenge in moving to this non-familiar format of submissions. Industries will now have to align themselves with various new technical requirements. We might soon witness Australia implementing a more convenient and highly effective format of eCTD.

• End-to-end support for submission of a New Drug Application (NDA) to the Saudi Food and Drug Authority (SFDA) including variations
• Preparation of regulatory submissions in compliance with SFDA guidelines
• Identification of applicable requirements, including regulatory requirements, market and customer drivers, etc.
• Enhance project delivery while standardizing regulatory operations
• Drive improvements in planning and delivery of critical submission project and generate process efficiencies

• Assessed 40+ Products across diverse Global Brands
• Submission of fast track Assessment Reports within 6 working days
• Significant Cost Benefits with Strategic advice on Claim Support for “To-be” marketed products

BUSINESS IMPERATIVES

The scope of project is to generate the regulatory and market intelligence data for Pharmaceuticals for seven countries in Sub Saharan Africa region identified by the client – Kenya, Ghana, Tanzania, Zambia, Angola, Nigeria and South Africa.

CHALLENGES

• The project required performing a Benefit and Risk Assessment Report on the product and Regulatory Filing Strategy
• The focus was to provide consultation in terms of the clinical safety tests required based on its available data, exposure and intended population

CLIENT BENEFITS

• Providing rational and scientifically sound clinical safety assessment in a time-bound frame ensuring cost effective solutions
• Effective communication with the formulators from different countries
• Helping client to streamline and harmonize Clinical Safety Assessment across all the business regions
• No clear information about the safety and efficacy of the product

FREYR SOLUTION & SERVICES

• Provide highly rational and scientifically sound clinical safety assessment to determine the clinical safety of the Client Products
• Minimize redundant testing for similar formulations
• Conducting literature search and compiling the scientific data to enable client to design strategy to elevate their efficacy and safety standards of their products

CLIENT BENEFITS

• Rationale, sound and scientific assessment enabling client to place the products confidently in market
• Fast track assessment report delivery timeline within 6 working days
• Strategic advice on claim support for to-be marketed products
• Significant cost-reduction by providing technical justification to support the safety of the product
• Freyr has assessed over 40 products across diverse global brands

• Master Dossier Creation for Future Markets
• Dossier Harmonization for 12 Countries
• 80% Time Effort Reduction
• 40% Savings on Cost of Compliance

BUSINESS IMPERATIVES

• The client needed support in filing 24 CMC variations for an established medicinal product in SA and SSA countries
• The product is used to treat haemorrhoids and other anorectal conditions.
• The scope included updating the registered information with current regulatory requirements and harmonize the dossier for 12 African countries for multiple dosage forms within short span of a few months

CHALLENGES

• The client faced strict timelines coupled with coordination across local markets
• Distributed country specific source documents
• Coordination with the proposed drug product manufacturing sites
• Country specific publishing requirements

CLIENT BENEFITS

• Compliance with product manufacturing change communication to health authorities in a timely fashion
• Harmonized master dossier approach and reduced the time effort by 80%
• 40% Savings on Cost of Compliance
• Master Dossier Creation for Future Markets

FREYR SOLUTION & SERVICES

• A unique approach to create a long term streamlined solution in addressing future change controls by harmonizing the country specific dossiers into a master dossier
• Gap Analysis
• Master Dossier Creation
• Country Variation
• Program Management Approach