FAQ

What is Regulatory Affairs?

Regulatory Affairs (RA) is a profession within the health care industry namely, Pharmaceuticals, Medical Device, Biologics, and Functional Food. The main role of this profession is to comply with Quality, Safety and Efficacy of the products as per the regulations laid down by the government.

 

 

 

WHAT IS IMPORTANCE OF REGULATORY AFFAIRS [RA] PREOFESSION

Regulatory Affairs (RA) is an upcoming dynamic and challenging profession within the Pharmaceutical industry, Biotech, Life Sciences, and healthcare products sector and vital in making safe and effective healthcare products available worldwide.

RA profession is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world. RA professionals play a crucial role right from the beginning of product development to post marketing authorization.

Regulatory affairs proficient is the very intersecting point in the middle of the regulatory authorities and the company whose positive or negative standpoint fosters the insight of the regulatory authority into the industry, for good or for bad. So, the better the scientific precision, the greater will be the chances for a product to come to the market within expected time.

Personalities who guarantee regulatory accordance and assemble the submissions or proposals together with those whose central job role is clinical affairs or quality assurance are all taken into account as regulatory affairs professional.

 

 

How attractive is the job market for RA Professionals ?

The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally. With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory laws, policies and procedures in pharmacy industry for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.

A new entity can cost several millions of rupees or dollars to progress. Surprisingly, even a few month deferrals in taking it to the market can have substantial impact on the monetary status of the company. One of the vital activities of the regulatory specialist is to ensure that the label of the product and related information of the patient has correctly been established and even a small mistake in any of the regulatory activities can make the product to be ready for recall in addition to the loss of several millions of money which is eventually bound to give rise to fall in self-assurance of financiers, health experts and finally the patients.

Are the courses conducted by Raaj GPRAC affiliated ?

YES, Raaj GPRAC is a well known institute and successfully completed 9years as GMP & REGULATORY CONSULTANT, AUDITORS & TRAINERS. Our courses are accreeeditated by NSDC under LSSSDC[Life science sectors skill development council]. We are ISO-29990-2010 certified institute. Our Institute operated by experienced people from Pharmacy Industry. All these certified courses have been designed as per the current Industrial norms and requirements.

The lectures/ training are being conducted by experts and stalwarts of the Pharmacy Industry who have more than 10 to 30 years of experience with reputed companies in the sector.

All experts share their experience & knowledge with Case-studies/examples and which would help the candidates to gain more knowledge about the subject.

Raaj GPRAC have collaborations with DIA, NIPER, JSS, ICT-UDCT, Global Compliance Panel, US, Maharashtra Educational Society’s HK College of Pharmacy, IPA-MSB, Bombay College of Pharmacy etc.

 

 

When are the classes conducted?

 Training Programs are conducted on Saturdays &  Sundays depending on availability of the guest faculties.

All the PG Diploma courses are conducted as Distance Learning Programs with Online Exam facility.

Do you have any fast track programs other than 6m PGDRA etc?

Yes. We are also offering various fast track programs to the industry and Academia Fast Track Training Programs are conducted on Saturdays &  Sundays depending on availability of the guest faculties.

All the PG Diploma courses are conducted CLASS ROOM and as Distance Learning Programs with Online Exam facility. There are many courses designed as per customer specific requirements

 

These are short duration courses for 1day/ 2-3 days/ 1 week/ 2 weeks or so. The Fast-track programmes are designed as per the individual customer requirements like Analytical, Formulation, Validations, QA, QM, RA, etc.

 

Who would benefit from these courses?

Freshers & Working professionals like RA professionals, QA. QC, R & D, Production, professionals, Fresher’s, Life Science Graduates/ Post Graduates, Pharmacy Graduates/ Post Graduates, PhDs, CRAs, Doctors, Clinicians, Professional working in the area of Formulation/ Production/ Quality Control/ R&D.

 

Are there any placement services provided by the institute?

Yes. The candidates who have enrolled with us will be helped to get the placements 100%. They will be provided with all guidance for Resume development, Interview techniques, soft skills, etc.till they are placed into industry.

 

What are the advantages of taking these courses?

  • Understanding of different Regulatory Bodies like Indian CDSCO, DCGI, USFDA, EMeA, MHRA, TGA, MCC, MHLW & RoW.
  • Overview of drug development process (Phase I, II, III, IV) and clinical trials.
  • Overview of cGMP, GLP, GCP etc.
  • Understanding of ICH topics from Q1, Q2, Q3…..to Q10.
  • Basics of CMC (Chemistry, Manufacturing & Control) and International Document Standards, Technical Writing/Review Rules.
  • Basic understanding of Analytical Method Development, Validation, Stability Testing.
  • Basic understanding of Formulation Development, Prototype, Writing PDR as per ICH Q-8.
  • Understanding of all Pharmaceutical Documentation required in the Industry (i.e. SOP, URS, Validation, GMP documents, BMR/BPR, Specifications, Test Procedures, Mfg. procedures, Packaging specs etc.
  • Understanding of CTD all modules I, II, III, IV & V. Overview of eCTD Submissions
  • Basic Understanding of eCTD modules, Granularity, Hyper linking, STF, PDF, Bookmarking etc. Assisting in Compiling & filing an eCTD Application.

What are the benefits of these courses to fresher students and experienced professionals?

Better option for Fresher’s & working professionals.

Help candidates strengthen their professional skills & Knowledge.

Experienced industrial faculties to deliver lectures & solve the queries.

Daily mails and UPDATES on pharma, Biotech  industry and happenings.

We take efforts that every student understands the course contents and placed into industry at suitable position.

 

How do I get login information?

  • Once you register for online course you will receive an email of user id & password, place an order of a course from your interest which will appear in purchased order. Once your order is placed,  you will received another mail for session link, instruction & schedule of course.

 

I'm not exactly sure which course will be right for me, can you help?

Yes, we will be glad to assist your course selection. Call us Monday-Saturday from 9.00am-6.00 pm at 9819125208, 9137913136, 9821144706. Or you can email us anytime at [email protected], [email protected], [email protected]

 

What is Clinical Research?

What is Clinical Research?

Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the clinical pharmacology (including pharmaco-dynamic and pharmaco-kinetic) or adverse effects with the objective of determining safety and efficacy of the new drugs.

Clinical Research is conducted in 4 phases

Phase 1 Trials:

This is the first phase where, the new drug is administered first time to a small number around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patients body and behaves in the predicted way.

Phase 2 Trials:

In this phase the medicine is administered to a group of approximately 100 – 300 informed patients to determine the effects and also to check for unacceptable side affects.

Phase 3 Trials:

In this phase the group selected is between 1000 – 5000, for the company to use statistics to analyze the results. If the results are favorable, data is presented to licensing authorities for a commercial license.

Phase 4 Trials:

This is a surveillance operation phase after the medicine is made available to doctors. who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

 

What is the growth of Clinical research Industry in India?

Clinical research is a multinational, multibillion and multidisciplinary industry. In recent years clinical research outsourcing to India has been increasing. This has largely been due to the availability of huge talent pool of investigators and clinical research professionals. Also, India has several prized attributes for clinical trial development, some of which are:

  • large and diverse patient pool
  • availability of medical, pharmacy and science graduates
  • excellent infrastructure facilities
  • comparative cost advantage
  • changes in the regulatory framework

 With India offering 10 years tax concession on revenue to local companies making research and development (R&D), investments, a substantial increase in R&D activities of both multinationals and domestic bio-pharmaceutical companies is inevitable.

Analysts are projecting that total clinical research spending in India will increase by more than 30% annually through 2020. A study by Ernst & Young indicates that total market value of clinical research activities performed in India is expected to grow to around USD 1.5 – 2 billion. Many Pharmaceuticals and Clinical Research Organizations have already come forward to unlock the vast potential that India has and are conducting clinical trials in India. Thus, there is expected to be a huge demand for qualified and trained clinical research professionals

How is Global Research Scenario?

The clinical research industry worldwide is growing at unparalleled rate. It has opened up new vistas for employment for a large number of trained professionals. The Clinical Research Market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the UK, and they form one-third of the total research & development staff. There are more than 2,50,000 positions vacant globally and salaries vary in the region of approximately USD 40,000 per annum for a Clinical Research Coordinator.

Today, UK Companies are eyeing tie-up to tap Clinical Research Market in India. (Economy Times 19th June 2006.)

What is Healthcare?

Healthcare is Prevention,Treatement and Management of illness and preservation of Mental and Physical well being through the services offered by the Medical, Nursing and Allied Healthcare Professionals.

According to WORLD HEALTH ORGANIZATION (WHO), healthcare embraces all the Goods and Services designed to promote Health including Preventive, Curative and Palliative inteventions wheather directed to the indivisuals or to populations and this organized provision is what constitutes "HEALTH CARE SYSTEMS".

What is the future of Healthcare Industry in India?

The total healthcare market in india is estimated to be US$30 Billions which coupled with increase in the Pharmaceutical Sector, would increase to US$ 58-75 Billions in the next five years with GDP increase between 6.2 % to 8.5 % . Private Organization spending accounts to 80 % of total Healthcare expenditure and private Healthcare will continue to be the largest component in the year 2012 and likely to double to US$ 35.7 Billions. Healthcare employees over 4 million people and immediate need

exceeds more than 2,00,000 Healthcare Professionals and by the end of the year 2012, india will need over 7,00,000 Healthcare Management Professionals and "YOU COULD BE ONE OF THEM". Furthermore, more hospitals are coming, and Goverment hospitals are inversting in latest technology and equipements.


 

What Our Fees covers?

  • Course Registration
  • Tuition fee
  • Course Material
  • Examination
  • Government Certification

 

 

KEY TAKEAWAYS FROM THE COURSE

  • On successful completion of the course get a Certificate of Completion from LSSSDC [Life science sectors skill development council] & RAAJ GPRAC.
  • Learn from and interact with the seasoned industrial Trainers to gain practical insights into the GLOBAL RA, QA-QC, CLINICAL, R & D, Mfg, PV, AUDITS, VALIDATIONS, COMPLIANCE & DOCUMENTATION.
  • Reviewing the procedure for IND, NDA, ANDA/ Generic products Filing in the US , Europe, Canada,RoW counries, LATAM, India and how to get an entry into those  market
  • Understanding and overcoming the challenges around rigid regulatory procedures
  • Examining how the DCGI are developing the approvals pathway to ensure international standards in safety and efficacy of drugs made in  India
  • ICH Topics, CDER guidance’s, 21FR parts, GMP, GLP, GDP, GCP aspects
  • Hands on training into CTD/eCTD/ACTD & Nees dossier preparations

 

I AM CONFUSSED ABOUT THE COURSES?

There is no need to be confused,because you are taking right decision in opting for career choice in growing industry such as Health Care & Clinical Research,which will provide you with ample CAREER GROWTH OPPORTUNITIES SUPPLEMENTED BY A SECURED FUTURE.

I AM NOT A DOCTOR. IS MBA FOR ME TOO?

Vast and rewarding healthcare industry offers careers to Medical as well as Non-Medical. Focus is laid on employing Healthcare Professionals to strenghten the Management of Hospitals and Healthcare Centres along with Medical Professionals. 

CAN I GO ABROAD AFTER MBA / MSC-CRRA?

Yes, both Clinical Research and Healthcare Industry offers Global Career to those who have knowledge, Skills and Ability (KSA) to manage efficiently & effectively the complexities in the respective industries.

DOES AIOHS OFFERS PLACEMENTS?

AIOHS does not function as a placement agency. But, Yes we do have dedicated Placement Cell which constantly interacts with industries and updates them on our educational programs and avalibilty of students for eployment. All available assistance is given to students for placements in industries.

 We have achieved 100 % Placements for last batch in MSC-CRRA Furthermore, our educational programs are so designed to increase the confidence level in our students to manage interviews on their own and comeout as WINNERS.

CAN I GET JOB BEFORE THE COURSE HAS COMPLETED?

Yes. but getting a job a will totally depands upon the knowledge, Skills and Ability to perform and managed the job. However you will be aided by our Placement Cell in providing Placement Assistance.

IS THERE AN OPTION FOR ATKT?

Yes, there is an option for ATKT. Please discuss with the counsellors.

CAN YOU PROVIDE CONTACT DETAILS OF PAST STUDENTS?

We have no objection in giving you contact details of our past students who are working in industries,

but we need to maintain protocal of acquiring apporval from them.

WHAT IS THE PATTERN OF THE EXAMINATION?

 University Exam Pattern is a multiple choice questions (MCQ).

I AM NOT AN EXPERT IN ENGLISH. WILL THERE BE A PROBLEM IN PLACEMENT?

There is no need for you to worry at all. At AIOHS, we offer Soft Skill Coaching in developing abilites inour student to communicate in English, and we conduct Personality Developement Workshops to make you employable. This is offered to students on request.

IF I AM NOT SELECTED AT THE FISRT ATTEMPT OF INTERVIEW, WHAT IS THE ROLE OF AIOHS?

 

Our dedicated team in the Placements Cells works on power methods of placement procedures where in, we train our students to approach interviews with confidence through role playing interview sessions with heads from industry. Furthermore, our Placement Cell will continue to provide assistance to the student till such time the student acquire job placement.

WHAT IS THE VALUE I WILL GET IN COMPLETING THESE DEGREE COURSES?

Every Student admitted to AIOHS is assured of A 3 FOLD VALUE that will

 1. Increase the Students MARKET VALUE

 2. Increase the students EMPLOYMENT VALUE

 3. Increase the students EARNING POWER

WHAT ARE THE BENEFITS I WILL GET FROM THESE COURSES?

1. You will be able to REALISE YOUR FULL POTENTIAL

 2. You will be able to UNDERSTAND SKILLSETS AND TALENT

 3. You will be READY FOR A RIGHT AND BRIGHT FUTURE

 4. You will INCREASE YOUR SELF-ESTEEM AS PROFESSIONAL IN INDUSTRY AND IN SOCIETY

 5. You will GAIN MANAGERIAL EXPERTISE IN MANAGING BOTH INDIVIDUALS AND     ORGANIZATION.

 6. You will HAVE EMPLOYMENT PREFERANANCE WITH GOOD DECENT ENTRY LEVEL     REMUNERATION PACKAGE.

What is regulatory affairs?

Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.

What are the goals of Regulatory Affairs Professionals?

Protection of human healthEnsuring safety, efficacy and quality of drugsEnsuring appropriateness and accuracy of product information

What are the Roles of Regulatory Affairs professionals?

Act as a liaison with regulatory agenciesPreparation of organized and scientifically valid NDA, ANDA,INDA ,MAA,DMF submissionsEnsure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and lawsProviding expertise and regulatory intelligence in translating regulatory requirements into practical workable plansAdvising the companies on regulatory aspects and climate that would affect their proposed activities Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.

What is an Investigational New Drug (IND) application?

It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA

What is a New Drug Application?

The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDAIn simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA

What is an Abbreviated New Drug Application (ANDA)?

It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.In simple words, “It is an application for the approval of Generic Drugs “

What is a Generic Drug Product?

A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
 

What is a DMF?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.Important facts regarding  DMFs It is submitted to FDA to provide confidential informationIts submission is not required by law or regulationsIt is neither approved nor disapprovedIt is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of theseIt is provided for in the 21 CFR (Code of Federal Regulations) 314. 420It is not required when applicant references its own information9.What are the types of DMF’s?Ans-Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug ProductType III: Packaging MaterialType IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their PreparationType V: FDA Accepted Reference Information (FDA discourages its use)
 

What is a 505 (b)(2) applicabtion ?

 505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.

What kind of application can be submitted as a 505(b)(2) application?

New chemical entity (NCE)/new molecular entity (NME)Changes to previously approved drugs

What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?

Change in dosage form.
 
Change in strength 
 
Change in route of administration Substitution of an active ingredient in a formulation product 
 
Change in formulation 
 
Change in dosing regimen
 
Change in active ingredientNew combination Product
New indication
Change from prescription indication to OTC indication
 
Naturally derived or recombinant active ingredient
Bioinequivalence

What are the chemical classification codes for NDA?

Number Meaning
 
1New molecular entity (NME)
 
2New ester, new salt, or other noncovalent derivative
 
3New formulation
 
4New combination
 
5New manufacturer
 
6New indication
 
7Drug already marketed, but without an approved NDA
 
8OTC (over-the-counter) switch

What are the differences between NDA and 505 (b)(2) application ?

All investigations relied on by applicant for approval were conducted by/for applicant and for which applicant has right of reference One or more investigation relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference2.Generally, filed for newly invented pharmaceuticals.Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical.Note: 505 (b)(2) application is a type of NDA.
 

What is a Marketing Authorization Application?

It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.As per UK’s MHRA-Applications for new active substances are described as 'full applications'.Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.

What is an ASMF?

Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.

What are the types of active substances for which ASMFs are submitted?

New active substancesExisting active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member StatePharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State

What is the difference between DMF and ASMF (with respect to submission)?

ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)There isn’t any differentiation of DMF’s into parts

What is ICH?

-International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

What is CTD?

The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc. 

 

What is a deviation and do all deviations need to be investigated?

A deviation is when there is a failure to follow the instructions guiding the performance of how an activity should be executed for optimal results. Simply put, deviations result from people not following their standard operating procedures (SOP), work instructions, batch record instructions, or other documents that explain what needs to be done in performing certain functions or tasks. Deviations relate to non-compliance and are a serious issue. While not all deviations are equal in their impact on product and quality, all should be investigated.

 

What is a planned deviation?

In our opinion, there is no such thing as a planned deviation. Planned deviations were supposed to justify changes from SOPs that would be utilized to carry out the operation over a certain period of time. The current thinking by regulatory authorities is there is no such thing as a planned deviation. During a breakfast session at the 2018 PDA/FDA Joint Regulatory Conference, a representative from the FDA stated, “it’s a very strange term, and it kind of makes your skin crawl a little bit” (1). If you need to make a change to a procedure for a short period of time, we suggest you use the change control system to document the change. This may seem like a picky point, but until the change is evaluated for its impact on the process validation requirements and formally documented in a change control, encouraging the deviations continued use is supporting a posture of non-compliance.

What’s the best process for investigating deviations?

There is no single best process for investigating deviations. The ultimate goal of deviation investigations is to determine why something went wrong, what caused it to go wrong, and how to address the issue and prevent its recurrence. To achieve successful resolution of deviations, keep the following general considerations in mind:

  • A one-size investigation doesn’t fit all situations. Simple errors require simple documentation while more serious deviations require broader investigations.
  • The best tool to have is inquisitiveness. Ask yourself how far this deviation could extend.
  • Widen your perspective. Look for ways to relate, not separate, similar issues.
  • Human error is rarely a sufficient root cause.
  • Always verify information or your instincts and never assume you are correct without proper data to support your instincts.

Why is human error not an acceptable finding for deviations?

The overuse of human error as a root cause to a deviation represents lost opportunities to reduce future issues by masking the identity of the true root cause. Herein is the human error in Human Error. The question that needs to be asked during the initial investigation into a deviation is what caused the employee to make the human error? Asking this question early in the investigation leads to better root cause identification and opportunities for continued improvement.

Let’s look at an example that might help clarify why human error can mask the real root cause of a deviation. Suppose, for example, you have a second shift manufacturing operator who continually forgets to sign a step in the batch record for a specific product. This operator is the only one who seems to have this issue. Your initial investigation into the first occurrence of the issue determines a root cause of human error. Because the operator works on the second shift, it is inconvenient to interview him directly, so you rely on the word of his supervisor that this was just a case of human error. You decide to retrain the operator on the proper use of filling out the form and skip the operator interview in order to complete the investigation and perform the retraining in the allotted 30-day time frame. This scenario repeats itself 10 times over the course of four months. You finally decide to interview the operator directly. When you talk to the operator, he informs you that in order to sign the batch record when it needs to be signed, he needs to exit the aseptic core, degown, sign the batch record, and regown, leaving the product unattended during that time. The operator tells you he chose to stay with the product and sign the batch record later but sometimes forgot after the manufacturing run. In this simple exchange with the operator, you realize that the root cause of the repeat deviation is not a result of human error but a result of poor process flow.

How much time should I allow for a deviation to be investigated?

The length of time it takes to complete an investigation depends on the complexity of the investigation. Simple deviations can be completed in a short time frame, but more involved deviations will take longer to complete. We recommend you set a time frame that is reasonable for your organization. For example, you might indicate that deviations will be investigated and completed between 30–60 days after the deviation was documented. This gives you some flexibility.

Are out-of-specification (OOS) results considered deviations?

No. OOS results need to be investigated separately and quickly due to the potential impact to the product. If the root cause of the OOS cannot be attributed to laboratory error, you should initiate a deviation/investigation to determine what happened during product manufacturing that attributed to the erroneous laboratory result.

 

WHAT IS IN VITRO DIAGNOSTIC REGULATION (IVDR)?

The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states

WHEN WAS THE IVDR IMPLEMENTED?

The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the commission and are stipulated to complete some of the requirements to be met.

WHEN DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY TO THE NEW IVDR?

From 26 May 2022 new devices will have to meet the requirements of the IVDR in order to be placed in the European market. Products already certified by a Notified Body may be placed on the market until 25 May 2024 under some conditions and if the manufacturer fulfill the specific prerequisite requirements drawn in the IVDR.

WHAT ARE THE KEY CHANGES EXPECTED IN THE NEW IVDR?

The actual terms of the proposed regulation are subject to change until final publication of the IVDR in the Official Journal of the European Union. Some of the key changes expected include:

  • Product scope expansion. Expanded scope will cover diagnostic (including Internet-based) services, genetic testing and other tests that provide information about a patient’s predisposition to a specific disease or susceptibility for a medical treatment.
  • Reclassification of devices according to risk. Risk classes will range from Class A for low risk devices to Class D for high risk devices. 
  • More rigorous clinical evidence. Manufacturers will need to conduct clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class.
  • Self testing and near patient testing devices will be subject to a premarket approval approach.
  • More stringent documentation.
  • Identification of ‘person responsible for regulatory compliance’
  • Implementation of unique device identification for better traceability and recall
  • Requirements for post market surveillance will be reasonably increased and general timeline for reporting reduced.
  • More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
  • Greater Scrutiny of Notified Bodies
  • No “grandfathering” provisions. All currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements.

WHAT ARE THE IMPLICATIONS OF THE NEW IVDR FOR IN VITRO MEDICAL DEVICE MANUFACTURERS?

The complex development process for in vitro diagnostic medical devices, combined with the anticipated changes, are likely to make the transition a complicated and time-consuming process for most device manufacturers. Manufacturers of in vitro diagnostic medical devices are well-advised to stay current on amendments to IVDR by Implementing and Delegated Acts, as well as additional changes that may impact them.

HOW DO I PREPARE FOR THE IVDR?

In preparing for the IVDR, it is important to inform yourself about the requirements and deadlines of the new IVDR. Additionally, it is important to perform an assessment of how your current product portfolio may be impacted by the new regulations.